| CTRI Number |
CTRI/2020/08/027242 [Registered on: 19/08/2020] Trial Registered Prospectively |
| Last Modified On: |
07/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Process of care changes] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of heat therapy on pain intensity during labor |
|
Scientific Title of Study
|
Effect of heat therapy on pain intensity, uterine contractions and duration of labor phases during first stage of labor: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujata |
| Designation |
M.Sc. (Nursing)Student |
| Affiliation |
AIIMS Rishikesh |
| Address |
Msc nursing, 1st year student, college of nursing, AIIMS Rishikesh
249201
India
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8171051356 |
| Fax |
|
| Email |
sanju.goswami.10091997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Prasuna Jelly |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
College of nursing, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9410103390 |
| Fax |
|
| Email |
prasunajelly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujata |
| Designation |
M.Sc. (Nursing)Student |
| Affiliation |
AIIMS Rishikesh |
| Address |
Msc nursing, 1st year student, college of nursing, AIIMS Rishikesh
249201
India
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8171051356 |
| Fax |
|
| Email |
sanju.goswami.10091997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sujata |
| Address |
Msc nursing 1st year student, college of nursing, AIIMS Rishikesh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sujata |
AIIMS Rishikesh |
Obstetrics and gynaecology department
Ward second
Room no. 219
Dehradun
UTTARANCHAL |
8171051356
sanju.goswami.10091997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hot water bag application |
Hot application will be applied on lower abdomen after the contraction during 1st stage of labor after 4cm cervical dilatation and 5 cycles will be provided to mother who is undergoing experimental group in the study and application is for 10 minutes and hot water bag is covered with cotton cloth after checking temperature of water with the help of thermometer. |
| Comparator Agent |
No intervention |
Standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primi mother undergoing NVD, willing to participate in the study
Primi mother with >37 weeks period of gestation, one single live fetus with cephalic presentation. |
|
| ExclusionCriteria |
| Details |
Primi mother under going NVD with-
Skin disease in the field of intervention.
Fetal distress.
Pharmacological pain relief measures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effect of heat therapy on pain intensity, uterine contractions and duration of labor phases among primi women in experimental and control group. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of heat therapy during labor among primiparous women. |
4 months |
|
|
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)
|
01/10/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomised controlled trial to assess the effect of heat therapy on pain intensity, uterine contractions and duration of labor phases during first stage of labor among primiparous women. OBJECTIVES: To assess and compare the effect of heat therapy on pain intensity, uterine contractions and duration of labor phases among primi mothers in experimental and control group. NEED OF THE STUDY: very few studies have been done on the application of heat therapy. UK studies found that midwives had used hot packs for reduction of labor pain during second phase of labor. METHODOLOGY: is quantitative approach, Randomized controlled trial design. Study setting is AIIMS Rishikesh, civil hospital rishikesh with target population Primiparous women having consecutive sampling techniques. |