| CTRI Number |
CTRI/2024/01/061881 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Corelational Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of Chronic Neck Pain with Function,Sleep and Work-Family Conflict in Nurses |
|
Scientific Title of Study
|
Co-Relation of Chronic Neck Pain with Function,Sleep and Work-Family Conflict in Professional Nurses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVijayalaxmi Kanabur |
| Designation |
Assisstant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of CBR
Second floor,KAHER Institute of Physiotherapy,JNMC Campus Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrVijayalaxmi Kanabur |
| Designation |
Assisstant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of CBR
Second floor,KAHER Institute of Physiotherapy,JNMC Campus Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrVijayalaxmi Kanabur |
| Designation |
Assisstant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of CBR
Second floor,KAHER Institute of Physiotherapy,JNMC Campus Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar ,Belagavi |
|
|
Primary Sponsor
|
| Name |
DrVijayalaxmi Kanabur |
| Address |
KAHER Institute of Physiotherapy
JNMC Belagavi |
| Type of Sponsor |
Other [Self Sponsered] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self sponsered |
Department of CBR .KAHER Institute of Physiotherapy,JNMC Campus,Nehru Nagar Belagavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVijayalaxmi Kanabur |
Room no 39 Department of PhysiotherapyKLE Dr.Prabhakar Kore Hospital and MRC |
Nehru Nagar,Belagavi Belgaum KARNATAKA |
8867480565
vvkdeeksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics committee,KAHER Institute of Physiotherapy,Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1.Both male and female nursing personnels
2.Nursing personnels with 2 years of work experience
3.Individuals complaining of neck pain since 3 months
• Individuals willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Individuals recently diagnosed with Upper limb fracture
2.Individuals diagnosed with neurological disorders
3.Nursing personnels undergoing treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.NUMERIC PAIN RATING SCALE
2.NECK DISABILITY INDEX
3.PITTSBURGH SLEEP QUALITY INDEX (PSQI)
4.WORK AND FAMILY CONFLICT SCALE
|
Baseline.(Since Observational study one time data would be collected) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="151" Sample Size from India="151"
Final Enrollment numbers achieved (Total)= "151"
Final Enrollment numbers achieved (India)="151" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
03/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Nursing is widely regarded as one of the most physically and emotionally demanding jobs in the world, with typical shift work causing a variety of acute and chronic health problems in nursing personnel.It is been found that Indian Nurses are more vulnerable to develop and is second largest MSD in Indian Nurses as they are engaged more in active patient care services and are strained more.In a research performed in Taiwan, they came over a conclusion that female nurses were advised to sleep for 7 hours per day to avoid neck and shoulder discomfort. Here there is a missing concern about male nurses.According to an article published in 2014,they found a positive relation between work-family conflict and health care workers but there were no study performed in nursing professionals.For the present study, work–family conflict is defined as a state in which there is an imbalance between an individual’s work and family roles where work responsibilities spill over to the family side. Organizational issues such as stressful work environments and inadequate human resources management practices are the main causes of work–family conflict. Unlike other professions, nursing mostly consists of women; therefore, nurses need to balance responsibilities at home and at work. Similarly, nurses encounter multiple and conflicting demands from patients’ needs, organizational and family-based demands. Therefore, it is not easy to maintain work–family balance while working shifts as well as the housework and childcare duties. These responsibilities increase stress levels and make nurses prone to work–family conflict.Therefore,it is difficult to maintain job and family expectations.In a study done in 2016, prevalence rate among female nurses with neck pain a time period of 12 months was found to be 34.5% and prevalence rate in time period of 7 days was found to be 16.2%.In a tertiary care hospital in Gujarat, the study revealed a high prevalence of MSD with perceived physical low back pain and knee pain ,but there was no co-relative study done between neck pain and work function among nurses. RESEARCH QUESTIONWhat is the co-relation of Chronic neck pain with function,sleep with work-family conflict in professional nurses? AIM To establish a co-relation of chronic neck pain with function, sleep and work-family conflict in professional nurses.
| PROCEDUREAfter Obtaining Ethical Clearance from Institutional Research Committee.All the participants will be examined on the inclusion and exclusion criteria before the study begins.The procedure will be explained to the participants and a written consent will be taken.Demographic data will be collected and the scales for the outcome measures will be administered.The included participants will be further graded using the scales listed :Numeric Pain Rating Scale (NPRS) ,Neck Disability Index (NDI),Pittsburgh Sleep Quality Index (PSQI) ,Work and Family Conflict Scale (WAFCS) .The data collected will be statistically analyzed. Results: The collected data were summarized by using the Descriptive Statistics frequency, percentage;mean and S.D. The Independent sample “t†test was used to compare age, BMI, years of workingexperience, neck pain, function, sleep, and work family conflict according to gender. To find therelation between age, BMI, working experience and neck pain, function, sleep, work familyconflict; the Pearson correlation coefficient (“râ€) was used. The p value 0.05 was considered assignificant. Data were analyzed by using the SPSS software (SPSS Inc.; Chicago, IL) version29.0.10. The current study included 151 participants both males and females out 0f which the Mean age 0f males was 29.8 with a SD 0f 7.1 and Mean age for females was 28.5 with a SD 0f 6.7 based on inclusion criteria. There was a variation in the BMI with a Standard deviation 0f 3.9 in males with average being 22.4 kg/m^2 and a Standard deviation 0f 4.0 in females with average being 21.7 kg/m^2. The descriptive statistic 0f Working experience also showed variation with Standard deviation 5.7 and average 0f 6.2 years 0f experience in males with females showing Standard deviation 0f 5.8 and an average also being 0f 5.8 years 0f experience. Using the Pearson correlation coefficient “r†along with help 0f NPRS, NDI PSQI and WAFCS scale it was found that there is a significant correlation between Neck Pain with Function (p value < 0.001) and Sleep (p value <0.001). Function also showed significant correlation with Sleep (p value < 0.001) and Work-Family Conflict (p value <0.001). Age factor also compared with help 0f Pearson coefficient showed positive correlation (p < 0.05) with neck pain, function and sleep. Years 0f work experience when compared showed positive correlation (p<0.05) with function and sleep. The comparison also showed males having a positive correlation with function, sleep and work-family conflict whereas among females neck pain was positively correlated with sleep, work-family conflict and also years 0f working experience.
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