| CTRI Number |
CTRI/2020/03/023848 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Preventive
Behavioral
Other (Specify) [Comprehensive Health literacy and Recorded Music on perinatal mental health and birth outcomes] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comprehensive Health-literacy And Recorded Music Intervention |
|
Scientific Title of Study
|
effectiveness of Comprehensive Health-literacy And Recorded Music (CHARM intervention)on perinatal mental health and birth outcomes among low risk primigravid women and neonatal dyads in a tertiary hospital, Udupi District, Karnataka-RCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meena Konsam |
| Designation |
Ph.D. Scholar |
| Affiliation |
MAHE, University |
| Address |
Department of Obstetrics and Gynaecological Nursing
4th floor, room no. 405
Manipal College Of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6364165228 |
| Fax |
|
| Email |
meenakonsam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meena Konsam |
| Designation |
Ph.D. Scholar |
| Affiliation |
MAHE, University |
| Address |
Department of Obstetrics and Gynaecological Nursing
4th floor, room no. 405
Manipal College Of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6364165228 |
| Fax |
|
| Email |
meenakonsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia RB DSouza |
| Designation |
Professor & Head |
| Affiliation |
MAHE,University |
| Address |
Department of Obstetrics and Gynaecological Nursing
6th floor, room no. 603B
Manipal College Of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09844732883 |
| Fax |
|
| Email |
udupisony@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of Nursing and Kasturba hospital, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Meena Konsam |
Kasturba hospital |
Kasturba Hospital
Department of Obstetrics and Gynaecology, Kasturba Medical College,
Antenatal Opd, ground floor room no. 1 & 2 and 3rd floor antenatal opd, Women and child block. Manipal, Udupi Dstrict- 576104, Karnataka
Udupi
KARNATAKA |
6364165228
meenakonsam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHARM intervention, Recorded music intervention , Comprehensive Health literacy information |
Recorded music intervention includes recorded instrumental Indian Classical music ie Hindustani ragas,
Comprehensive health literacy information includes care during third trimester, delivery care and maternal and neonates care.
CHARM intervention include both package of recorded music and comprehensive health literacy information |
| Comparator Agent |
Standard of care |
standard of care which includes antenatal care given by the treating physician |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Low-risk primigravid women
above 28 weeks of gestation but also includes women who may have had a previous abortion of less than 20 weeks of gestation.
who can read and speak English and Kannada
who are having normal hearing ability
women who possess a smartphone
have a vertex or cephalic presentation
|
|
| ExclusionCriteria |
| Details |
Primigravid women
with psychiatry disorder and endocrine disorders (like Gestational Diabetes mellitus, thyroid) and adrenal problems
multiple gestation pregnancy
In-vitro fertilization (IVF), assisted reproductive treatment pregnancies
diagnosed to be at risk for preterm delivery and who had delivered preterm neonate previously.
with pregnancy-related complications such as antepartum haemorrhage, preeclampsia, and pregnancy-induced hypertension, gestational hypertension and cervical incompetence.
with confirmation of congenital anomalies before 28 weeks of gestation
clinically identified as having Intrauterine growth restriction before 28 weeks of gestation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pregnancy related anxiety |
baseline data , after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
perinatal mental health: quality of sleep, antenatal unipolar depression,
peirnatal birth outcome, health literacy, neonatal behaviour, LATCH score |
baseline, after 4 weeks of intervention , post delivery |
|
|
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)
|
12/03/2020 |
| 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="3"
Months="1"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Pregnancy is the period where most of the women change both physiological and psychological aspects. Normally fear and anxiety occur throughout her daily life concerning her state of health and her growing fetus The present study aims to assess the effectiveness of Comprehensive Health-literacy and Relaxing Music (CHARM) intervention, only comprehensive health-literacy, and only relaxing music intervention on pregnancy-related anxiety, quality of sleep, health literacy and perinatal birth outcomes among low-risk primigravid women. Low-risk primigravid women are in need of necessary information regarding their pregnancy and required care. So, making their literate in health-related information in need of the hour. Similarly, they are also anxious respect to their pregnancy, so listening to recorded music will help them to alleviate their anxiety. Moreover CHARM in a cost-effective manner which may contribute to improve perinatal outcomes. If found effective, getting comprehensive and necessary health information and listening to recorded music as an intervention can be implemented among pregnant women throughout the pregnancy period to alleviate anxiety, improve health literacy about pregnancy and thereby improve perinatal outcomes. The hypotheses will be tested at 0.05 level of significance H1: there will be significant difference in perinatal mental health outcomes between the experimental group and control group H2: there will be significant difference in birth outcomes between the experimental group and control group |