| CTRI Number |
CTRI/2024/06/068719 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Nurse Led Intervention Regarding Prevention Of Home Accidents Based On Protection Motivation Theory] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of nurse led intervention regarding home accidents among mothers of under five children. |
|
Scientific Title of Study
|
A mixed method study to determine risk factors affecting mothers behaviors regarding home accidents and evaluate effectiveness of nurse led intervention regarding prevention of home accidents based on protection motivation theory referred to selected rural area in Anand district Gujarat Sate |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Binal Joshi |
| Designation |
Assistant professor |
| Affiliation |
Manikaka Topawala institute of nursing, charotar university of science and technology |
| Address |
Room 202, Manikaka topawala institute of Nursing, CHARUSAT university, Charusat Campus, Changa, Taluka- Petlad Anand, Gujarat 388421 , India
City Anand
State Gujarat
Anand
GUJARAT
388421
India |
| Phone |
9913149039 |
| Fax |
|
| Email |
binaldjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Binal Joshi |
| Designation |
Assistant professor |
| Affiliation |
Manikaka Topawala Institute of Nursing, Charotar University of Science and Technology |
| Address |
Room no. 202, Manikaka Topawala Institute of Nursing, CHARUSAT University, Charusat Campus, Changa, Taluka- Petlad Anand, Gujarat 388421 , India
City Anand
State Gujarat
GUJARAT
388421
India |
| Phone |
9913149039 |
| Fax |
|
| Email |
binaldjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Sharma |
| Designation |
Principal cum Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing, Charotar University of Science and Technology |
| Address |
Room no, 101, Manikaka Topawala Institute of Nursing, CHARUSAT University, Charusat Campus, Changa, Taluka- Petlad Anand, Gujarat 388421 , India
City Anand
State Gujarat
Anand
GUJARAT
388421
India |
| Phone |
8140364743 |
| Fax |
|
| Email |
principal.mtin@charusat.ac.in |
|
|
Source of Monetary or Material Support
|
| The Medical Officer
Primary Health Centre,
Bandhani,
Taluk: Petlad
District: Anand
State: Gujarat
Pin Code:388410 |
| The Medical Officer
Primary Health Centre,
Piplav,
Taluk: Sojitra
District: Anand
State: Gujarat
Pin Code:388460 |
| The Medical Officer
Primary Health Centre,
Sihol,
Taluk: Petlad
District: Anand
State: Gujarat
Pin Code:388130 |
|
|
Primary Sponsor
|
| Name |
Nill |
| Address |
Nill |
| Type of Sponsor |
Other [Nill] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janvi Shah |
Primary Health Center Bandhani |
Medical officer
primary Health Center
Bandhani Gujarat 388001
Anand
GUJARAT |
7567870140
00
phcbandhani.health.anand@gmail.com |
| Dr Twinkle Macwan |
Primary Health center Piplav |
medical Officer
Primary Health center Piplav
Petlad Gujarat 388460
Anand
GUJARAT |
917359006625
00
phcpiplav.health.anand@gmail.com |
| Dr Chintan Rabari |
Primary health center sihol |
Medical officer
Primary health center
sihol
Sihol, Gujarat 388130
Anand
GUJARAT |
7567870138
00
phcsihol.health.anand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CHARUSAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mothers of Under five children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The name of the intervention is "Nurse led Intervention on Prevention of home accidents." |
The duration of the Nurse led intervention will be for four weeks.
The frequency of the intervention is one session in a day
It will be delivered through
1. Meeting one-to-one, face-to-face contact session for five hours during first four days for five hours in total
Contact session of Day I: 1.5 hour: stages of growth and development
Contact session of Day II: 45 minutes: Home accidents: types and risk factors
Contact session of Day III: 45 minutes: Individual-tailored counselling on prevention of home accidents
Contact session day IV: 2 hours : Demonstration and discussion about Perform first aid training, Mock drill/ Nursing intervention on First aid of wound for burns and fall injury with help of manikin Manikin and Distribution of first aid kit with demonstration of usage
2. Non meeting intervention duration with workbook on prevention of home accidents for next 25 days. The participants will be given Workbook On Prevention of Home Accidents at home. The participants in the intervention arm instructed to read and practice prescribed exercises from the workbook on prevention of home accidents for four weeks.
The subjects in the intervention will participate in pretest on first day followed by post test on 4 th and 30 th day of intervention. |
| Comparator Agent |
The subjects in the control arm will not receive any intervention. |
As this is a control group, no any intervention will be given. The subjects in the control arm will participate in the pretest before intervention . Post-test will be conducted at the end of 4th day and 30th day. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Mothers having at least one child within the age under five years
2) Mothers who have at least one self-reported home accidents
3) Mothers who are willing to participate in the study
4) Mothers aged 18– 40 years
5) Mothers registered under PHC/CHC at least from last 6 months
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1) Mothers who are not available at the time of data collection
2) Mother has other serious illnesses or illnesses not suitable for this study;
3) Mother is unable to complete 4 week of follow-up.
4) Mother is unwilling or unable to provide informed consent; and
5) Mother is currently participating in other intervention studies
6) Mother is Illiterate (As a part of intervention Information workbook will be provided on growth and development of child, types of home accidents, preventive measures and they have to fill colors where safety is applicable and/or mothers with medical diagnosis of cognitive/behavioral disorders were excluded from this research
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behaviors of Mothers regarding prevention of Home accidents |
4 weeks/30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A mixed method Study to determine risk factors affecting mothers’ behaviors regarding home accidents and evaluate effectiveness of Nurse led intervention regarding prevention of home accidents based on protection motivation theory referred to selected Rural area in Anand District Gujarat state. Objectives 1.Determine risk factors affecting mothers’ behaviors regarding home accidents. 2.Determine pre interventional level of mother’s behavior about home accidents 3.Evaluate the effectiveness of Nurse led interventional programme on mother’s behavior regarding home accidents in terms of 1. Improvement in Knowledge related to prevention of home accidents 2. Change in Perceived Severity 3. Change in Perceived vulnerability, 4. Change in Response efficacy 5. Change Self efficacy 6. Perceived response cost 3.3.a. Before Intervention 3.3.b. Immediately after intervention 3.3.c 4 weeks after intervention. Methodology Ø Research approach: - Mixed method approach Ø Research design: A Sequential Explanatory Design | Phase 1 Quantitative | Phase 1. A | Cross sectional approach | Determine risk factors regarding home accidents | | Phase 1. B | Randomised control trial | Evaluate effectiveness of Nurse led intervention on prevention of home accidents | | Phase 2 Qualitative | Phase 2 | Descriptive phenomenological | Process evaluation |
|