The Effects of Antenatal Interventions With Artistic Content Given to Pregnant Women

January 23, 2021 updated by: Sibel Kıyak, Necmettin Erbakan University

The Effects of Antenatal Interventions With Artistic Content Given to Pregnant Women on Mental Health and Maternal Attachment Levels

Aim:This study aimed to evaluate the effects of music listening, laughter therapy, and diary keeping, given as group sessions to pregnant women in the last trimester on mothers' overall mental health and maternal attachment status in the postpartum period.

Method: The study was a nonrandomized study including a control group for which the post-test procedure was performed alone. The measurements were also repeated at intervals for those in the intervention group. The study was conducted in two separate family health centers.The women with the following constituted the study inclusion criteria: Pregnant women over the age of 18, those with pregnancy between 16-24 weeks of gestation, and those with literacy in Turkish. The data were collected through Beck Depression Inventory, Edinburg Postpartum Depression Scale, Brief Symptom Inventory, and the Maternal Attachment Scale to comprehensively evaluate mental health status. All participants responded to the personal information form prepared for the study.

Keywords:Antenatal care, depression, diary, laughter therapy, maternal attachment, music listening

Study Overview

Detailed Description

The intervention group consists of pregnant women in the second trimester who were registered with two family health centers.The Gpower 3.1.9.2. program was used to determine the number of participants in both groups. The sample size was found as 25 for each group by accepting the effect size to be wide (0.82), the alpha value (0.05), and the power (0.80). In the experimental group, sampling adequacy for within comparisons was evaluated with Gpower 3.1.9.2. program. It was determined that the sample was sufficient for partial eta squared values obtained from the study. (10 participants were adequate for each group).The researcher (SK) obtained the list of registered women with a pregnancy between 16-24 gestational weeks. Based on the inclusion and exclusion criteria, the participants were included in the intervention group via face-to-face interviews. Informed written consent was obtained from each participant, and the interventions were performed in this group. Mothers receiving standard antenatal care in the prenatal period, giving birth, and having a three-month-old baby constituted the control group. The control group was created after the procedures were completed for those in the intervention group.

Interventions such as music listening, laughter therapy, and diary keeping were carried out for each woman in the intervention group.A six-session antenatal care program included both music listening and laughter therapy and was designed for those in the study group as a session every week. The program was carried out by arranging a music session for one week and a laughter therapy session over the following week. Also, the notes uttered by pregnant women were discussed at the week laughter listening sessions were performed. Data from the intervention group were collected four times as pretest (after providing informed contest), first-interval measurement (fourth week of the intervention), second-interval measurement (the first month following the birth), and post-test (the third month following the delivery). Even so, the post-test was administered only for the controls.

The data pooled after the study were analyzed using the computer software of SPSS 22.0, OpenMeta[Analyst], and JAPS 09.0 statistical analysis packages. The findings were tested at p<0.05 of the significance level.Similarity analyses of the study and control groups were performed with chi-square (the Pearson and Yates correction). The post-test scores of BDI, EPDS, BSI, and MAS in the intervention and control groups were compared through the t test in independent groups, and Cohen's d and confidence interval (CI) was utilized in the assessment of effect size. Four measurement results of the intervention group were compared with those of variance analysis through repeated measurements, and the partial eta square and CI were used to evaluate the effect size. Two-way variance analysis for repeated measurements was used in evaluating the group/time interactions of the changes in terms of the overall mental health scores of the group with and without depression symptoms in the intervention group at the four time-point.In Cohen's d calculation, if d is 0.20, 0.50, and 0.80, the calculation demonstrates small, medium, and large effect sizes, respectively (d≤ 0.20 weak, d<0.50 medium and d≥ 0.80 large effect size). However, in evaluating the partial eta square, 0.01, 0.06, and 0.14 were considered small, medium, and large, respectively.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Konya, Turkey, 42090
        • NECMETTİNEU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women over the age of 18,
  • Between 16-24 weeks of gestation,
  • Can understand and speak Turkish,
  • Pregnant women who agreed to participate in the study after giving information about the study and those with literacy in Turkish.

Exclusion Criteria:

  • A psychiatric disorder (through self-reporting),
  • The existence of chronic disease for laughter therapy (heart diseases, hypertension, hemorrhoids, urinary incontinence, and epilepsy, etc.),
  • Pregnancy with infertility treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: İntervention group
A six-session antenatal care program included both music listening and laughter therapy, and was designed for those in the study group as a session every week. The program was carried out by arranging a session of music listening for one week and a laughter therapy session over the following week. Also, the notes uttered by pregnants women were discussed at the week laughter listening sessions were performed. Data from the intervention group was collected four times as pretest (after providing informed contest), first-interval measurement (fourth week of the intervention), second-interval measurement (the first month following the birth) and post-test (the third month following the birth).The data were collected through Beck depression Inventery (BDI), Edinburg postpartum depressıon scale EPDS, Brief semptom ınventory(BSI) and maternal attachment scale(MAS) evaluate overall mental health status comprehensively. All participants responded to the questionnaire prepared for the study.

Laughter therapy was carried out by the researcher as a total of three sessions every 15 days, and each session lasted 30 minutes.

Participants listened to the types of music that they like (pop, Turkish folk music). In the meeting room in FHC, Two professional artists performed music recitals with a guitar and saz (qopuz) to pregnant women, and pregnant women actively participated in this process. The performance was carried out as three sessions, once every 15 days, and each session took 40 minutes.

In addition to music listening and laughter therapy, the pregnant women were asked to keep a diary to write down their emotions about their health status, pregnancy and baby. Then, each participant had an opportunity to explain her emotions or replies to the questions during the group therapy sessions every 15 days so that pregnant women were able to express their feelings.

No Intervention: Control group
Mothers receiving standard antenatal care in the prenatal period, giving birth, and having a three-month-old baby constituted the control group. The Control group was created after the procedures were completed for those in the intervention group. Only the post test was applied to the control group.The data were collected through Beck depression Inventery (BDI), Edinburg postpartum depressıon scale EPDS, Brief semptom ınventory(BSI) and maternal attachment scale(MAS) evaluate overall mental health status comprehensively. All participants responded to the questionnaire prepared for the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Beck Depression Inventory
Time Frame: Change from baseline to 24 weeks

Mental Health:The Beck Depression Inventory (BDI) is a 21-item self-reporting scale consisting of emotional, cognitive, somatic and motivational components to measure the level and severity changes of depressive symptoms. In BDI, it is seen that as the total score obtained from the scale increases, the individual's level of experiencing depressive emotions increases proportionally. In addition, BDI scores can be classified as minimal depression between 0-9 points, mild depression between 10-16, moderate depression between 17-29, and severe depression between 30-63 points.

The intervention was applied at 16-24 weeks of gestation and at the 3rd month of postpartum.

Change from baseline to 24 weeks
Edinburg Postpartum Depression Scale
Time Frame: Change from baseline to 24 weeks

Mental Health: The Edinburg Postpartum Depression Scale (EPDS) was designed with the aim of screening to determine the risks of depression in pregnancy and postpartum periods. However, EPDS cannot be used to diagnose depression. EPDS is a 4-point likert self-reporting scale and consists of 10 items.

The intervention was applied at 16-24 weeks of gestation and at the 3rd month of postpartum.

Change from baseline to 24 weeks
Brief Symptom Inventory
Time Frame: Change from baseline to 24 weeks

Mental Health:Brief Symptom Inventory was developed to determine the individuals' depression, anxiety, sleep, somatization, obsessive-compulsive disorder and interpersonal sensitivity status as the short form of SCL-90-R Scale.The items are scored between 0 and 4, corresponding to "none" and "too much". BSI has three global indexes as discomfort severity, total symptom and discomfort symptom indexes. The increase obtained from the scores in these indexes demonstrates individuals' negative experiences regarding overall mental health status.

The intervention was applied at 16-24 weeks of gestation and at the 3rd month of postpartum.

Change from baseline to 24 weeks
The Maternal Attachment Scale
Time Frame: The third month following the birth
Maternal Attachment:The Maternal Attachment Scale (MAS) measures the attachment for maternal affection.MAS is a 4-point Likert-type scale with 26 items, each ranging from "always" to "never". The score obtained from the scale varies between 26 and 104.
The third month following the birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

August 29, 2018

Study Registration Dates

First Submitted

January 2, 2021

First Submitted That Met QC Criteria

January 23, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 23, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NecmettinEU_Kiyak

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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