Antenatal CareNCT04728256
The Effects of Antenatal Interventions With Artistic Content Given to Pregnant Women
A study testing Laughter therapy+Music listening+Keeping diary in people with Antenatal Care and Mental Health, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Care, Mental Health
- What is being tested?
- Laughter therapy+Music listening+Keeping diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2018to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Antenatal Care, Mental Health
- Being tested
- Laughter therapy+Music listening+Keeping diary
- Keywords
- Antenatal care, Depression, Diary, Laughter therapy, Maternal attachment, Music listening
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter therapy+Music listening+Keeping diaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The third month following the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start5 Mar 2018
- Primary completion15 May 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal CareStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Kıyak, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728256
- Sponsor's protocol ID
- NecmettinEU_Kiyak
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antenatal Interventions With Artistic Content Given to Pregnant Women on Mental Health and Maternal Attachment Levels
- ClinicalTrials.gov ID
- NCT04728256
- Acronym / sponsor ID
- NecmettinEU_Kiyak
- Conditions
- Antenatal Care, Mental Health
- Keywords
- Antenatal care, Depression, Diary, Laughter therapy, Maternal attachment, Music listening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Behavioral: Laughter therapy+Music listening+Keeping diaryA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter therapy+Music listening+Keeping diaryLaughter 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. | Behavioural | İntervention group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter therapy+Music listening+Keeping diary in people with Antenatal Care and Mental Health, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Beck Depression Inventory (time frame: Change from baseline to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.