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

NCT04728256 | Completed

• 1 other identifier: NecmettinEU_Kiyak
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Antenatal Care; Mental Health

Keywords

Antenatal care; Depression; Diary; Laughter therapy; Maternal attachment; Music listening

Outcome Measures

Primary Outcomes (4)

• The Beck Depression Inventory

  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

  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

  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

  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

Study Arms (2)

İntervention group

EXPERIMENTAL

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.

Behavioral: Laughter therapy+Music listening+Keeping diary

Control group

NO INTERVENTION

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.

Interventions

Laughter therapy+Music listening+Keeping diary BEHAVIORAL

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.

İntervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettineu

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 28, 2021
• Study Start: March 5, 2018
• Primary Completion: May 15, 2018
• Study Completion: August 29, 2018
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)