Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302641397841 Date of Approval: 16/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Music Psychotherapy During Pregnancy on Maternal Depression, Anxiety, Health Changes After Delivery and Neonatal Outcomes at Adventist Hospital, Bekwai Municipality
Official scientific title Effect of Music Psychotherapy During Pregnancy on Maternal Depression, Anxiety, Health Changes After Delivery and Neonatal Outcomes at Adventist Hospital, Bekwai Municipality
Brief summary describing the background and objectives of the trial The ability to process and perceive sensory stimuli is critical for human beings. The onset of fetal hearing occurs at about 24 weeks of gestation [1]. In utero, the growing neural system is subject to excess of stimuli that might have far-reaching implications [2]. It is appealing to study if maternal psychological and neonatal outcomes could be improved in a similar manner. Music psychotherapy is a noninvasive and culturally wide acceptable intervention that has numerous hypothesized direct and indirect benefits for mother and fetus during pregnancy and the postpartum period [3]. Music has been shown to provide psychological advantages, such as lowering stress, anxiety, and depression, as well as improving sleep quality in sleep-deprived pregnant women [4, 5]. Music therapy is an excellent treatment option for anxiety and depressive disorders [37]. A systematic review and meta-analysis also indicated that music therapy decreases depression symptoms, although that evaluation was confined to trials including older individuals [6]. In addition, music therapy could help to lower a woman's heart rate and arterial blood pressure along with an increase in fetal movements and fetal heart rate [7-9]. Psychological symptoms such as depression and anxiety during pregnancy can have a significant impact on the fetus's future psychosomatic and intellectual development [10]. Previous studies have assessed the effect of depressive symptoms on adverse neonatal outcomes and found maternal depression was associated with increased risks of low birth weight (LBW), and infant mortality and morbidity [11]. The present study will be carried out to test the hypothesis that music psychotherapy during pregnancy may improve maternal psychological and neonatal outcomes. Objectives (1) To examine the effect of music psychotherapy during pregnancy on maternal depression and anxiety levels (2)To evaluate the effect of music psychotherapy during pregnancy on maternal and neonatal outcomes
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Psychological Morbidity and Pregnancy Outcome
Purpose of the trial Treatment: Other
Anticipated trial start date 15/03/2022
Actual trial start date 05/04/2022
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date 28/06/2022
Anticipated target sample size (number of participants) 1433
Actual target sample size (number of participants) 360
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Music psychotherapy Music listening period will be 40 minutes every session, three times a week at the same time. 6 weeks, with 18 individual sessions Music psychotherapy will be a home-based program, with the exception of a request to be seen in a separate location; it will begin at week 32 weeks of gestation and lasted 6 weeks, with 18 individual sessions. The music listening period will be 40 minutes every session, three times a week at the same time. Local gospel tunes will be played at a moderate volume at the ambient level, with no headphones. To prevent interference from outside stimuli, the music will be listened to in a silent room with no noise or background noise. The participants will be expected to sit in a semi-position, Fowler's with their heads and shoulders slightly raised but not asleep. The comparison group followed their usual antenatal routine without any intervention. 180
Control Group Standard care N/A At 36 weeks of gestation and immediately after delivery (<8weeks postpartum) After booking, women in the study groups will continue to receive their regular care from their staff midwives and physicians. Midwives make decisions about how frequently to meet pregnant women depending on their needs and available resources on a regular basis. All individuals will have access to normal care throughout the experiment, which include prescribe medications and other treatments that will be offered by the institution. 180 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligible pregnant women will be those who (i) had scored Patient Health Questionnaire-9 (PHQ-9) score≥10 at screening .The PHQ-9 is a 9-item self-report screening measure for depression symptoms, which is widely used in clinical practice and research. (ii) Age > or =18years old, not require urgent medical or psychiatric attention, and was able to give informed consent personally. (iii) Pregnancy at second trimester at the time of screening and recruitment. (iv) Not exposure to drugs, other than those prescribed by their gynecologist and (v) who had no early being diagnosis with anxiety and depression symptoms. on the other hand, are qualities that exclude potential participants from participation in the research. Pregnant women will be excluded if they were already getting treatment or if they did not live in the research region on a permanent basis (i.e. less than 6 months’ residency). If a fetal anomaly will be discovered during ultrasonography, or if there will be obstetric difficulties or a significant psychosocial risk at the time of recruiting, the candidate will be ruled out. Adult: 19 Year-44 Year 18 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/09/2022 Komfo Anokye Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Bantama-Kumasi Kumasi 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression, Anxiety disorders, Apgar scores, fetal heart rate on admission variable, heart rate of the newborn at the time of discharge, respiratory rates, axillary temperatures, birth weight, newborn length and head circumference At 36 weeks of gestation , 2 to 8weeks postpatrum
Secondary Outcome Postern pregnancy, hours between admission and delivery, mode of delivery , episiotomy/tear, gestational age at delivery, hemoglobin at delivery, systolic blood pressure and diastolic pressure at delivery, postpartum hemorrhage, antepartum hemorrhage, obstructed labor, pre-eclampsia, hypertension at term, anemia at term, Postpartum urinary tract infection, endometritis or retained product of conception, initiated skin to skin care within 30minutes, breast feed in 30 minutes, postpartum depression At delivery and immediate after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dominase Adventist Hospital AB-11104396 Kumasi 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
The Principal Investigator AB 111-04396-Dominase Kumasi 00233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Vera Anokkyewaa Amponsah AB1401-4067 Kumasi 00233 Ghana Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries KwaKu Poku kpoku@gmail.com +233542325771 AB 1157-9890
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana University of Cape Coast
Role Name Email Phone Street address
Public Enquiries Cecilia Amponsah amponsahbooateng@dmail.com +233244173442 A1086-4178
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Domestic Bursar
Role Name Email Phone Street address
Principal Investigator Kwabena Acheampong acheampong1980@gmail.com +233545506106 ab-1110-4699
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Public Health Officer Valley View University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information