1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
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3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [roy.deblina001@gmail.com].
   


6. For how long will this data be available start date provided 19-12-2025 and end date provided 19-05-2024?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Brief Description Of The Study And Summary

PROBLEM STATEMENT :.( The Effect Of Selected Psychological Nursing Intervention On Quality Of Life And Coping Among Burn Patients Undergoing Plastic and Reconstructive Surgery In Tertiary Care Centre, of North India: A Randomized Control study)

Introduction:

Burns have been extremely traumatic and so can be their treatments therefore this has been reportedly associated strong and lasting psychological impacts ⁵. Studies across the world have reported that the psychological impact of the patients with burns have effected their quality of life  at  2 months , 6months and an year after the injury also amounts to a major complication with long term consequences ⁶.  The most commonly reported  psychiatric conditions across the world is ASD which is around 18-26% of the cases in the western countries⁷.  Studies from Japan and United States have reported development of PTSD in almost 1/4^th of the populations in the aftermath of burns. Also  in theaftermath of Burns the patients have reported to be developing depressive disorders ⁸.  There is an array of psychological symptoms  that have been reported in Burn patients like; body-image disturbances⁶, sleep disturbances, insomnia⁹, scar related problems¹⁰. Furthermore it has been shown that psychological stress can impact the wound healing at a significant rate and can be attributed to poorer prognosis of the patient suffering from burn Injury ¹¹. The Allostatic model describes that the higher psychological stress can impact the body’s immune response and overloading of the Allostatic systems therefore leading to exhaustion of the reserves and malfunction in the change adaptation of the person going through stress.  Therefore precipitating long-term psychological complications^12(ps).   therefore there is a strong need to intervene at the psychological level to have better outcomes for the patients suffering fromburns. 

AIM: To study the effectiveness of add-on Brief psychological nursing intervention on Quality of life and coping among burn patients undergoing plastic surgery in a tertiary care Centre, Lucknow UP.

OBJECTIVES:

To develop a  selected psychological intervention module targeted towards patients suffering from burns undergoing plastic surgery. 

    To Determine the effectiveness in recovery outcomes and compare that to standard treatment with respect to Quality of life and coping in experimental and control groups.

Correlate the findings with clinical and socio-demographic variables. 

NEED FOR THE STUDY: 

Burns have severe psychological impacts on patients, affecting their quality of life and leading to long-term consequences. Acute Stress Disorder (ASD) is the most common psychiatric condition worldwide, with  (Post Traumatic Stress Disorder) PTSD and depressive disorders also being reported. Burn patients experience body image disturbances, sleep disturbances, insomnia, and scar-related problems. Psychological stress can impact wound healing and poorer prognosis. The Allostatic model suggests that higher psychological stress can overload the body’s immune response, leading to exhaustion of reserves and malfunction in change adaptation. Therefore, psychological intervention is crucial for better outcomes. Therefore there is a huge need among patients regarding targeted and specialist psychological interventions for severe burn cases that require plastic surgery as a management, therefore I decided to conduct the study so that effective modules could be developed for their help and alleviation of their suffering.

STUDY AREA: Department of Plastic Surgery, King George’s Medical University Lucknow UP.

STUDY POPULATION: Patients registered and admitted in the Department of Plastic Surgery for treatment of burns receiving treatment for the same. 

INCLUSION CRITERIA:

Patients more than 18 years of age.

Patients having burn injuries and receiving treatment. 

Patients being treated in the IPD of the Department of Plastic Surgery for its management.

Willing to give consent to participate.

Participants who understand Hindi.

The patient is hemodynamically stable. 

EXCLUSION CRITERIA:

Patients in the Intensive Care Unit. 

Patients suffering from any previous major psychiatric Illness. 

Deaf and Mute patient, If the patient is unable to communicate effectively. 

If the patient develops a secondary infection.

Critical medical illness and other medical comorbidities. 

DROPOUT CRITERIA:

Death Of participant

Any emergence of serious medical Issues that may impact the study 

Misses more than 2 follow-ups will be considered dropout.

SAMPLE SIZE AND SAMPLING TECHNIQUE:

According to calculated sample size with effect size of >25 (small) 

F tests - ANOVA: Repeated measures, within-between interaction

Analysis: A priori: Compute required sample size

Input: Effect size f = 0.25

α err prob = 0.05

Power (1-β err prob) = 0.95

Number of groups = 2

Number of measurements = 4

Corr among rep measures = 0.5

Nonsphericity correction ε = 1

Output: Noncentrality parameter λ = 18.0000000

Critical F = 2.6937209

Numerator df = 3.0000000

Denominator df = 102

Total sample size = 36

Actual power = 0.9517650

The calculated sample size was 36. 

As there will be chances for attrition and drop out approximate margin of 20% is taken above the calculated sample size and 60 participants will be included in the study.

Calculated sample size is  36 Target sample size is 60  using Random sampling technique.

Keeping in mind the attrition 10 percent  and adding up to 20 percent drop out and rounding off at least 60 patients will be enrolled in the study.  

STUDY DESIGN:

In this randomized control trial,participants will be randomly selected and allotted in the experimental and control groups. There will be an initial baseline assessment of the patients in both the groups, GHQ12, BSHS RDA, and  BRIEF COPE, then the experimental group shall receive the  module of the intervention that will address the current state of their recovery which will last for 30-45 mins which will burn related interventions and patient-specific interventions.  The control group shall receive a nonspecific and general health guideline for 30 minutes.  Thereafter both the groups will be called in for followup after 1 month and the experimental group shall receive the module of the intervention both containing (burn related interventions and patient specific intervention) and control group will receive the nonspecific interventions and the assessment will be carried out with the tools. There after they will be called after a month and experimental group shall receive the 3^rd module of intervention and followed by assessments. the control group shall receive nonspecific interventions and the assessment will be carried out with the tools. Then both the groups will be seen 1 month after  for  final assessment thereby the RCT will have  3 points of  intervention and 4 points of assessment in both the groups. 

TIME FRAME:

 2 years. 

RESEARCH HYPOTHESIS

H0: There is no significant difference in the outcome of burn patients of the experimental group and the control group with respect to psychological issues, their body image and quality of life.

H1: There will be significant differences in the outcome of burn patients of the experimental and control groups with respect to psychological issues, coping, body image and quality of life that have received brief psychological intervention.

REVIEW OF LITERATURE

Dalal P.K., Saha R, Agarwal M (2010)¹³published a review on the aspects of issues faced by the  patients who suffer from burns  and the aspects of pain and psychological aftermath of burns  during  immediate and long term management of burns. they had reviewed 63 studies and narratively described their findings and different models that were used to understand the associated stressors which had strong impact on the outcome and management of burns. their findings reported that the pain during the management of the burns had lasting impacts on the psychological well-being of the patients and if not mediated timely could cause delay in wound healing and negatively impact the physical and psychological aspects of survivors of burns.  the model allosteric load and how It impacts the wound healing; also, the bio-psychosocial model to achieve better pain management and positive outcome.

Weichman SA, Patterson D R (2004) ¹⁴conducted a study among survivors of burn injuries  where they had specifically discussed about the psychological requirement of burn patients during various phases of  treatment,  according to  their finding, brief psychological interventions  have benefit where there is no pre-existing  depression or anxiety before the occurrence of burns.  According to the researchers the requirement of interventions often change during the acute and the  long term care times and psychological interventions can  have lasting positive impact on the treatment outcomes of patients with burns.

Brret D, et al ( 2008)¹⁵ conducted a. study on the longitudinal study on the body imageof patients with severe burn injuries.  They conducted the study on 79 participants, using the satisfaction with Appearance Scale (SWAP) and assessed them at 6 and12 months post discharge, they found that being female and burn on the total body surface area, appearance were key factors that effected their body image at (p < 0.05) levels.  The study findings reported that body image distress was reported to be an important factor that mediated the relationship between the pre burn and 12month post burn psychological function. They recommended a routine psychological intervention to improve the outcome of post hospitalization and after discharge.

Shepherd L, Tattersall H & Buchanan H (2014)¹⁶reported in a retrospective mixed method research design study conducted  post 2 month period of patients suffering from burns in the UK.  A total of 200 participants took part in the study among them only 18% responded to their questionnaire, the study reported that the participants reported that almost ½ of them had apprehension to look in the mirror. The major factors that effected their distress were found to be comparisons according to expectations from treatment, satisfaction from help received. The researchers suggested that a psychological intervention would be necessary to manage such cases while patients are recovering from the burns.

Duke J M et, al (2018)¹⁷conducted a population based retrospective cohort study of burns that were sustained during childhood  in Western Australia. The study period was taken from 1980-2012; with a sample size of 11967 children. The study found that post burn mental health admissions were higher.  The rate of psychiatric help seeking was twice as high among the ones that suffered from burns younger than 5 years of age compared to the uninjured children. The hospitalization rates were 5 times higher among the children who were injured between ages of 10-14 years  and  most of them suffered from mood and anxiety disorders followed by psychotic disorders followed by disorders due to alcohol and drug use. They had recommended that mentalhealth support was needed for patients suffering from burns for a long term to prevent psychiatric co-morbidity associated their psychosocial and academic issues. 

Woolard A et al,( 2021)¹⁸conducted a systematic review of pediatric burn injuriesand synthesized the literature with the goals of understanding the  psychological impact of pediatric burn injuries and the risk that it poses for the development of psychopathology  in their future; the authors included 45 studies from 17 countries to finally analyze the data. Their findings suggest that there is increased chances for development of anxiety, traumatic stress response, depression, self-harm , self-esteem and self-concept related issue in future, they recommended that further research is needed to determine outcomes and targeted mental health interventions need to be studied to improve the outcome of care for such cases. 

Mouncey P R et al (2019) ¹⁹conducted a nurse led preventive  psychological intervention to reduce PTSD symptom severity in Critically ill patients  using a cluster randomized control tiral for critically ill patients in Critical care units. They used 2 side by side study designs. One was garner feasibility of the intervention, educational tools, support tools. Then a multicentric parallel group cluster RCT was conducted with a baseline period and staggered roll out of the intervention. The outcome of the study was measured using PTSD Symptom scale and questionnaire to assess clinical effectiveness and quality adjusted life years at 6 months and life time cost effectiveness. Total 127 participants were recruited for intervention feasibility and 86  for the RCT for feasibility. The multicentric trials were randomized from 24 randomly selected sites and divided into intervention and control groups and a total  of 1458  participants were recruited  the intervention Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI)] was studied and nurses were trained and then  more than 80% of the 24 sites delivered the intervention in time.  On an average the intervention reduced the costs and slightly improved QALY leading to positive benefit at 6 months around 835 pounds. But there was no significant difference between the groups for any secondary outcomes. The limitations of the study included lack of blinding and patients were not assessed for delirium routinely during the critical care hospitalization. It could be concluded from the study that  the preventive psychological intervention for level 3 patients  hospitalized in critical care for more than 48 hours did not make a difference when it came to PTSD symptom severity at 6 months when compared to usual care. 

Guthrie E et al, (2001) conducted a randomized control trial of a brief psychological intervention after deliberate self-poisoning.  They aimed to assess the effectiveness of (brief psychodynamic interpersonal therapy) and compare it with the usual treatment and patients satisfaction with care in a community based setting. They used four sessions of therapy delivered at patients home and a referral back to their general practitioner. The severity of suicidal ideations was assessed after the intervention by the beck scale of suicidal ideations. Participants in the intervention group had significantly higher reduction in suicidal ideations at 6 month follow up.  They reported higher satisfaction with treatment and were less likely to report repeated acts of self-harm.

Shao D, Gao W, Cao F L, (2016)²⁰conducted a randomized control trial of brief psychological intervention in patients with cervical cancer. As it is a known stressful diagnosis and a major life stress with potential harmful effects on psychological wellbeing. Therefore, a randomized control trial was conducted in 3 centers of China using waitlisted randomized control design- and 120 patients were assigned randomly to intervention and control group.  The participants did a pre and post self-report of positive and negative affect, rumination and reappraisal before and after 4-week intervention period. Significant improvement was found on all the outcome measures. the brief psychological intervention improved positive affect and reappraisal and reduced negative affect and rumination in women with cervical cancer. Therefore, they recommended the use of brief psychological interventions in oncology.

Miller-Matero L et al, (2021)²¹studied the effectiveness of brief psychological intervention for chronic pain in primary care setting with a randomized control trial as a primary care setting in USA.  60 patients were enrolled in a 5-session psychological intervention and a treatment as usual group. There was a higher drop-out on control group and experimental group showed positive results in terms of pain severity, pain catastrophizing and depression the anxiety scores showed no significant reduction. The researchers concluded that brief psychological intervention for chronic pain in primary care could be a gateway to further behavioral pain management techniques and recommended such studies at larger scales. 

Ahuja RB et al, (2016)²²conducted a study on 60 burn survivor patients using  Burn specific Health Scale brief (BSHS-B) to assess their quality of life post the burn Injury,  their findings reported that majority of the patients were illiterate and more than half (60%) were females. The median TBSA burn was 30%. The study was conducted with patients around 10 months post treatment. The findings reported that patients scored highly on the domains of simple abilities and mobilities, function of hands, and the Interpersonal relationships. They also scored poorly on the skin sensitivity and body image. This study findings help us understand about the outcomes of burns and recommend psychological interventions for burn patients and their rehabilitation.

TOOLS:

GHQ 12:  The GHQ 12 (items) is based on the 60 item Goldberg’s GHQ, the brief version from English was translated and standardized by  Gautam S, Nijhawan M, Kamal P, 1987¹  in Hindi, it was translated and retranslated into Hindi and tried on 500 patients, mean age was found to be 30.5 years,  reliability of translation retranslation was found to be 96%.  The Pearson product moment correlation was found to be 0.78. Therefore, it was reported to be used for IPD, and OPD patients to screen for any mental health issues, the scores of 15 and above means definite psychiatric cases, and people scoring between 8-15 have probable psychiatric diagnoses, therefore the score of more than 3 indicates the presence of psychiatric issue and more than 7 a possible psychiatric condition. The tool has been used effectively to differentiate any psychiatric illness from the general population.

BSHS (RDA):  Burn Specific health scale is a 40-item tool to assess the  Quality of Life for the people that have underwent burn related injury in their life, the Hindi adaptation was done by Mulay A et al, 2015 ².  They found while doing their study in order to validate the tool that Kappa value for the interrater reliability was 0.748 and Cronbach’s a the internal consistency of the tool was found to be ranging from 0.443-0.908, the scale showed good discriminant validity in 31-36 domains. Making the tool a valid and reliable instrument to assess the quality of life of the people who are affected by burns. 

COPE BRIEF:The main tool is developed by Carver C S, 1997 ³ with 14 domainswhere as follows: Self-distraction, Items 1-19; Active coping Items -2 and 7, denial, Items 3and 8, substance abuse items 4 and 11; Use of emotional support, items 5 and 15 use of Instrumental support, items 10-23, behavioral disengagement items 6 and 16; venting items 9 and 21. Positive reframing Items, 12 and 27; Planning items 14and 25, Humor items 20 and 24. Religion items 22 and 27. Self-Blame; items 13 and 26.  There is no such thing as an "overall" score on this measure, and I recommend no particular way of generating a dominant coping style for a give person. The reliability of the tool was found to be Cronbach’s Alpha- 0.75. this tool has been translated and validated in various languages and has been found to be of similar efficacy. 

The scoring patterns need to be assessed in the following way; 

1 = I haven’t been doing this at all

 2 = I’ve been doing this a little bit

 3 = I’ve been doing this a medium amount

 4 = I’ve been doing this a lot. 

TECHNIQUE:

Direct interview will be used to carry out the interventions and assessments.

 Fig 1:  flow diagram of conducting the Randomized control, Trial.

Fig 2: Consort Diagram of The Study.

STATISTICAL ANALYSIS:

Shapiro Willke’s test will be applied to find the data is parametric or not. If the data is found to be parametric then for inter group comparison of categorical variables Chi square test will be applied for comparison of continuous variables Unpaired t test will be applied. Within the group comparison will be applied for repeat measures of ANOVA. If the data is found to be non-parametric the comparison will be used Mawhinney U test for continuous variables and Fischer’s exact test for categorical variables.  Repeat measures of ANOVA/ Krushkalwallis test will be used to assess within group measures for non-parametric variables. 

Correlational analysis will be done by using Pearson’s correlation if the data parametric and spearman correlation if the data is non parametric. 

ETHICAL CLEARANCE

Ethical Approval Has been Obtained from the Institutional Ethics Committee of KGMU. Ref No: 130^th ECMIIB-Ph.D/P6

Written informed consent from the subjects or caregivers will be obtained under which the following issues will be addressed:

1. There will be a complete explanation of the requirements of the study.

2. The subjects or caregivers will be assured that there will not be any interference or influence of the research process on the treatment, irrespective of whether or not consent for the study is given. Management of patients will get priority over the assessment for the study.

3. Any personal information regarding the patient, which comes to the candidate’s knowledge, will be kept confidential. Simultaneously, any relevant clinical data regarding the patients/ subjects will or management that comes to light during the study will be passed on to the treating team.

4. Subject shall have the right to withdraw from the study at any point in time without having any negative consequences on his treatment.

REFERENCES

1.         Gautam S, Nijhawan M, Kamal P. Standardisation of hindi version of goldbergs general health questionnaire. Indian J Psychiatry. 1987;29(1):63-66.

2.         Mulay AM, Ahuja A, Ahuja RB. Modification, cultural adaptation and validation of burn specific health scale-brief (BSHS-B) for Hindi speaking population. Burns. 2015;41(7):1543-1549. doi:10.1016/j.burns.2015.05.008

3.         Carver CS. You want to measure coping but your protocol’s too long:  Consider the Brief COPE. International Journal of Behavioral Medicine. 1997;4:92-100. Accessed February 20, 2023. https://local.psy.miami.edu/people/faculty/ccarver/availbale-self-report-instruments/brief-cope/

4.         Lawrence JW, Heinberg, L. J, Roca, R, Munster, A., Spence, R., Fauerbach, J,A. Development and validation of the Satisfaction With Appearance Scale: Assessing body image among burn-injured patients. Psychological assessment. 1998;10(1):67-70. doi:https://doi.org/10.1037/1040-3590.10.1.64

5.         Dalal PK, Roy D, Choudhary P, Kar SK, Tripathi A. Emerging mental health issues during the COVID-19 pandemic: An Indian perspective. Indian J Psychiatry. 2020;62(Suppl 3):S354-S364. doi:10.4103/psychiatry.IndianJPsychiatry_372_20

6.         Fauerbach JA, Lezotte D, Hills RA, et al. Burden of burn: a norm-based inquiry into the influence of burn size and distress on recovery of physical and psychosocial function. J Burn Care Rehabil. 2005;26(1):21-32. doi:10.1097/01.bcr.0000150216.87940.ac

7.         Patterson DR, Ptacek JT, Cromes F, Fauerbach JA, Engrav L. The 2000 Clinical Research Award. Describing and predicting distress and satisfaction with life for burn survivors. J Burn Care Rehabil. 2000;21(6):490-498.

8.         Madianos MG, Papaghelis M, Ioannovich J, Dafni R. Psychiatric disorders in burn patients: a follow-up study. Psychother Psychosom. 2001;70(1):30-37. doi:10.1159/000056222

9.         Ehde DM, Patterson DR, Wiechman SA, Wilson LG. Post-traumatic stress symptoms and distress 1 year after burn injury. J Burn Care Rehabil. 2000;21(2):105-111. doi:10.1097/00004630-200021020-00005

10.       Low JFA, Dyster-Aas J, Willebrand M, Kildal M, Gerdin B, Ekselius L. Chronic nightmares after severe burns: risk factors and implications for treatment. J Burn Care Rehabil. 2003;24(4):260-267; discussion 259. doi:10.1097/01.BCR.0000075847.26303.37

11.       Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995;346(8984):1194-1196. doi:10.1016/s0140-6736(95)92899-5

12.       McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993;153(18):2093-2101.

13.       Dalal PK, Saha R, Agarwal M. Psychiatric aspects of burn. Indian J Plast Surg. 2010;43(Suppl):S136-S142. doi:10.4103/0970-0358.70731

14.       Wiechman SA, Patterson DR. Psychosocial aspects of burn injuries. BMJ. 2004;329(7462):391-393. Accessed February 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC509350/

15.       Thombs D, Notes LD, Lawrence JW, Magyar-Russel J, Bresnick MG, Faurbach JA. From survival to socialization: A longitudinal study of body image in survivors of severe burn injury - ClinicalKey. Journal of Psychosocial Rsearch. 2008;64(2):205-212. Accessed February 7, 2023. https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0022399907003613?returnurl=https:%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0022399907003613%3Fshowall%3Dtrue&referrer=https:%2F%2Flink.springer.com%2F

16.       Shepherd L, Tattersall H, Buchanan H. Looking in the mirror for the first time after facial burns: A retrospective mixed methods study - ClinicalKey. Burns. 2014;40(8):1624-1634. Accessed February 7, 2023. https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0305417914001107?returnurl=https:%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0305417914001107%3Fshowall%3Dtrue&referrer=https:%2F%2Flink.springer.com%2F

17.       Duke JM, Randall SM, Vetrichevvel TP, et al. Long-term mental health outcomes after unintentional burns sustained during childhood: a retrospective cohort study. Burns & Trauma. 2018;6(1):32. doi:10.1186/s41038-018-0134-z

18.       Woolard A, Hill NTM, McQueen M, et al. The psychological impact of paediatric burn injuries: a systematic review. BMC Public Health. 2021;21(1):2281. doi:10.1186/s12889-021-12296-1

19.       Mouncey PR, Wade D, Richards-Belle A, et al. A Nurse-Led, Preventive, Psychological Intervention to Reduce PTSD Symptom Severity in Critically Ill Patients: The POPPI Feasibility Study and Cluster RCT. NIHR Journals Library; 2019. Accessed February 10, 2023. http://www.ncbi.nlm.nih.gov/books/NBK545679/

20.       Shao D, Gao W, Cao FL. Brief psychological intervention in patients with cervical cancer: A randomized controlled trial. Health Psychol. 2016;35(12):1383-1391. doi:10.1037/hea0000407

21.       Miller-Matero LR, Hecht LM, Miller MK, et al. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021;22(7):1603-1611. doi:10.1093/pm/pnaa444

22.       Ahuja RB, Mulay AM, Ahuja A. Assessment of quality of life (QoL) of burn patients in India using BSHS-RBA scale. Burns. 2016;42(3):639-647. doi:10.1016/j.burns.2015.11.011