Clinical trial NCT04728256: The Effects of Antenatal Interventions With Artistic Content Given to Pregnant Women
Official title: The Effects of Antenatal Interventions With Artistic Content Given to Pregnant Women on Mental Health and Maternal Attachment Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antenatal Care
Mental Health
Keywords: Antenatal care
Depression
Diary
Laughter therapy
Maternal attachment
Music listening
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 intervention group was carried out with a total of 50 pregnant women, 25 of whom were controls.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Beck Depression Inventory
timeFrame: Change from baseline to 24 weeks
measure: Edinburg Postpartum Depression Scale
timeFrame: Change from baseline to 24 weeks
measure: Brief Symptom Inventory
timeFrame: Change from baseline to 24 weeks
measure: The Maternal Attachment Scale
timeFrame: The third month following the birth
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettineu
Study officials:
References: