| CTRI Number |
CTRI/2018/10/015949 [Registered on: 09/10/2018] Trial Registered Prospectively |
| Last Modified On: |
05/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Educational] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of preoperative education on anxiety and coping mechanism among children and parents before undergoing surgery |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL TO ASSESS EFFECTIVENESS OF PREOPERATIVE EDUCATIONAL SCHEDULE (PES) ON ANXIETY AND COPING MECHANISM AMONG CHILDREN AND THEIR PARENTS AT ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Trial Acronym |
PES (Preoperative educational schedule) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhu Yadav |
| Designation |
M.Sc. Nursing |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
3rd floor,College of Nursing, Pediatric Nursing Department,AIIMS, Rishikesh
3rd floor,College of Nursing, Pediatric Nursing Department,AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9760554495 |
| Fax |
|
| Email |
madyadav555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Malar Kodi S |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
3rd floor,College of Nursing, Pediatric Department,AIIMS, Rishikesh
3rd floor,College of Nursing, Pediatric Department,AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9760554495 |
| Fax |
|
| Email |
malar.nur@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Madhu Yadav |
| Designation |
M.Sc. Nursing |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
3rd floor,College of Nursing, Pediatric Department,AIIMS, Rishikesh
3rd floor,College of Nursing, Pediatric Department,AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9760554495 |
| Fax |
|
| Email |
madyadav555@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH. |
|
|
Primary Sponsor
|
| Name |
Madhu Yadav |
| Address |
Room NO. 147, NURSING GIRLS HOSTEL , AIIMS, Rishikesh
UTTARAKHAND |
| Type of Sponsor |
Other [SELF FUNDED BY PRINCIPAL INVESTIGATOR] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Madhu Yadav |
AIIMS RISHIKESH |
Pediatric Department
Dehradun
UTTARANCHAL |
9760554495
madyadav555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Science, Rishikesh, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z639||Problem related to primary supportgroup, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
usual practice |
Control group will not be received preoperative educational schedule intervention and anxiety and coping mechanism will be assessed before and after the operation. |
| Intervention |
Pre operative educational schedule |
Experimental group will be shown a video of 15 min which include explanation of preoperative care, medication used during anesthesia & instrument used during surgery, operation theatre visit and post-operative care. Anxiety and coping mechanism will be checked through standard tool before and after the surgery. Control group will not be received preoperative educational schedule intervention and anxiety and coping mechanism will be assessed before and after the operation. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children in age group of 6 to 12 years old admitted with their parents.
The children and their parents who are present at the time of data collection and willing to participate in research study.
Children who are undergoing minor and major elective surgery like umbilical hernia, inguinal hernia, Anorectal malformation and hypospadias.
|
|
| ExclusionCriteria |
| Details |
Children who are diagnosed as mentally challenged and developmental delay.
Children who are admitted in pediatric emergency for surgery, had previous surgery or hospitalization.
Who are using of anti-anxiety drugs and having chronic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant difference between the Pre and Post- intervention level of anxiety and coping mechanism among children and their parents in experimental and control group at p 0.05 level. |
15-18 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be significant association between the level of Anxiety and Coping mechanism in Experimental and Control group among children and their Parents with their Socio-demographic variables at p0.05 level. |
15-18 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomized control trial to assess effectiveness of
Preoperative Educational Schedule (PES) on anxiety and coping mechanism among
children and their parents at All India Institute of Medical Sciences,
Rishikesh. The primary outcome will be significant difference between the Pre
and post- intervention level of
anxiety and coping mechanism among children and their parents in experimental
and control group at p<0.05 level. the secondary outcome will be significant association
between the level of anxiety and coping mechanism in experimental and control
group among children and their parents with their sociodemographic variables at
p< 0.05 level. |