Postpartum DepressionNCT05038085
Postpartum Depression and Maternal Attachment
A study testing progressive muscle relaxation exercise in people with Postpartum Depression and Progressive Muscle Relaxation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In terms of postpartum care and depression, follow-up and controls should be continued online in order not to interrupt the follow-up and treatment of women. In this context, in order to prevent the development of postpartum depression and to increase maternal attachment, it is planned to deliver the progressive… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Progressive Muscle Relaxation
- What is being tested?
- progressive muscle relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2021to Jun 2022
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being at least literate
- Being at least 18-35 years old
- Being between 35-36 weeks of pregnancy
- Not having any psychiatric diagnosis
- Not being pregnant at risk
- Being pregnant naturally
Show all 9Show fewer
- Having the technical means to use Whatsapp® application
- Volunteering to participate in the research
- Not having a communication barrier
Who cannot join
- Having a stillbirth
- Hospitalization of the newborn
- Hospitalization of the mother
- The woman's desire to leave the research
- Not filling out data collection tools
- Unable to reach for training/consulting
- The woman's progressive relaxation exercise less than three days a week
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, Çankaya, 06440
Gazi ÜB Fakültesi
About this study
Official title: The Effect of Health Education and Progressive Muscle Relaxation Exercise Program Applied Online on Postpartum Depression and Maternal Attachment: a Randomized Controlled Study
In terms of postpartum care and depression, follow-up and controls should be continued online in order not to interrupt the follow-up and treatment of women. In this context, in order to prevent the development of postpartum depression and to increase maternal attachment, it is planned to deliver the progressive muscle relaxation exercise and individual health education program that we planned in our study through online applications. This study will be conducted to evaluate the effect of online health education and progressive muscle relaxation exercise program on postpartum depression and maternal attachment.The study was planned as a parallel randomized controlled experimental study conducted in a Family Health Center in Ankara, with a single-center, stratified block randomization (parity: primiparous, multiparous; EPDS score: 0-9, 10-30).The number of pregnant women to be included in the study was calculated as 56.Personal Information Form, Prenatal Attachment Scale, Edinburgh Postpartum Depression Scale and Postpartum Attachment Scale will be used to collect data.
Read the detailed description
Sample Power analysis was performed to determine the number of samples. For this, the information in a similar study (Aydın Özkan et al., 2020) was used as a reference. The minimum number of participants required to be included in each group was determined as 24, with a total of 48 (α=0.01, 1-β=0.95). However, considering the loss rate (18.75%) in Aydın Özkan's study, which was taken as a reference, the total number of participants was determined as 56 (experimental: 28, control: 28).
Randomization In order to prevent imbalance between the groups, pregnant women will be assigned to the experimental and control groups by the tanned block randomization method. Pregnant women will be stratified according to parity (primiparous-multiparous) and Edinburgh Postpartum Depression Scale score (0-9 points, 10-30 points). In this context, 8 groups will be formed as shown below.
Set 1: Primiparous and pregnant women with EPDS scores between 0 and 9 Set 2: Primiparous and pregnant women with a EPDS score of 10-30 Set 3: Multiparous and pregnant women with EPDS score between 0 and 9 Set 4: Multiparous and pregnant women with a EPDS score of 10-30 Data Collection Personal Information Form, Prenatal Attachment Scale, Edinburgh Postpartum Depression Scale and Postpartum Attachment Scale will be used to collect data.
The purpose and content of the study will be explained by interviewing 35-week-old pregnant women who applied to FHCs for pregnancy follow-up. Their compliance with the sampling inclusion criteria will be evaluated. Then, an informed consent form will be signed by the pregnant women who agree to take part in the study. Personal information form, Prenatal Attachment Scale and Edinburgh Postpartum Depression Scale will be administered to pregnant women participating in the research. Then, the pregnant women will be randomized by stratified blocking according to their parity and EPDS score averages, and the assignment of the experimental and control groups will be made. Contact information (Phone numbers and e-mail addresses) will be taken at the first encounter.Experimental Group Application 36-37 with pregnant women in the experimental group. There will be a total of two online interviews, once a week, starting from the first week. Before the first interview, women will be sent a PKGE video explained by the researcher via e-mail or Whatsapp application, and they will be asked to watch it before the interview. In the first meeting, basic information about postpartum depression and what to do to prevent postpartum depression will be explained. The women will then be asked to describe the PKGE. The interview will be terminated when it is confirmed that the women have understood correctly and fully. Afterwards, "Relaxation Exercises CD Audio Recordings" belonging to the Turkish Psychological Association will be sent to the women, and they will be asked to do PCGE at least 3 days a week until delivery, accompanied by the instructions on the CD. In the second meeting; If postpartum depression develops, what should be done and maternal attachment will be explained, and women's opinions and questions about PCGE will be taken. In this interview, women will be asked to continue PCGE at least 3 days a week from the day they feel ready, starting at the latest 1 week after delivery.
During the application process to women, "Don't forget to do your relaxation exercise" every other day, "Weekdays to talk to your nurse about the training issues you have received. Weekend …. You can call or send a message about the issues you want to consult between the hours of the day. message will be sent. If the woman wants to have an interview, she will be called at the specified times and interviewed and the participant's questions will be answered. If it is noticed that an issue that needs help from different disciplines or that a postpartum complication develops, he will be referred to the hospital.
The Edinburgh Postpartum Depression Scale and the Postpartum Attachment Scale will be administered at the sixth week postpartum. The scales will be converted into an online questionnaire and mothers will be asked to fill in by sending their contact address.
Control group application Prenatal Attachment Scale and Edinburgh Postpartum Depression Scale will be administered to women at 35 weeks of pregnancy, Postpartum Attachment Scale and Edinburgh Postpartum Depression Scale will be administered to women at 6 weeks postpartum. The scales will be converted into an online questionnaire and women will be asked to fill in by sending their transportation address. No intervention will be applied to the women in the control group during the study.
- Being tested
- progressive muscle relaxation exercise
- Keywords
- postpartum depression, maternal attachment, progressive muscle relaxation exercise, online health education
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxation exerciseBehavioural
Also called health education
36-37 with pregnant women in the experimental group. There will be two online interviews starting from week one. Before the first interview, the PMRE video will be sent to the women, explained by the researcher. In the first meeting, basic information about postpartum depression and what to do to prevent postpartum depression and its treatment will be explained. The women will then be asked to describe the PKGE. "Relaxation Exercises CD Audio Recordings" belonging to the Turkish Psychological Association will be sent to women, and they will be asked to perform PMRE at least 3 days a week until delivery, accompanied by the instructions on the CD. In the second meeting; maternal attachment will be explained. In this interview, women will be asked to continue to do PMRE at least 3 days a week from the day they feel ready, starting at the latest 1 week after delivery.
| Study group | Role | What they receive |
|---|---|---|
| experimental group application | Experimental | progressive muscle relaxation exercise health education Receives: Behavioral: progressive muscle relaxation exercise |
| control group application | No intervention | No intervention will be made in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Edinburgh Postpartum Depression Scale (EPDS), Prenatal Attachment Scale (PAS)
PAS and EPDS will be administered to women at 35 weeks of pregnancy.The scales will be converted into an online questionnaire and mothers will be asked to fill in by sending their contact address.
The lowest score that can be obtained from EPDS is 0 and the highest score is 30.Women with a total scale score higher than the cut-off point are considered to be a risk group in terms of postpartum depression.A minimum of 21 points and a maximum of 84 points can be obtained from the PBE. The increase in the score obtained by the pregnant indicates that the level of attachment also increases.
Measured: prenatal 35. week
Secondary outcomes (1)
The EPDS, The Postpartum Attachment Scale (PPAS)
The EPDS and the PPAS will be administered at the sixth week postpartum. The scales will be converted into an online questionnaire and mothers will be asked to fill in by sending their contact address.The lowest score that can be obtained from EPDS is 0 and the highest score is 30.Women with a total scale score higher than the cut-off point are considered to be a risk group in terms of postpartum depression.The cut-off point for PPAS is 26 points. A score of 27 or more from the overall scale is defined as having a postpartum attachment problem.
Measured: postpartum 6. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start25 Oct 2021
- Primary completion8 Apr 2022
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Uçakçı Asalıoğlu, Gazi University
- Investigators
- Şengül Yaman Sözbir, Assoc., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038085
- Sponsor's protocol ID
- 2021 - 175
- Status last verified
- Apr 2022
- First submitted
- 16 Jul 2021
- Last updated
- 14 Apr 2022
- 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education and Progressive Muscle Relaxation Exercise Program Applied Online on Postpartum Depression and Maternal Attachment: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05038085
- Acronym / sponsor ID
- 2021 - 175
- Keywords
- postpartum depression, maternal attachment, progressive muscle relaxation exercise, online health education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Sep 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.
In terms of postpartum care and depression, follow-up and controls should be continued online in order not to interrupt the follow-up and treatment of women. In this context, in order to prevent the development of postpartum depression and to increase maternal attachment, it is planned to deliver the progressive muscle relaxation exercise and individual health education program that we planned in our study through online applications. This study will be conducted to evaluate the effect of online health education and progressive muscle relaxation exercise program on postpartum depression and maternal attachment.The study was planned as a parallel randomized controlled experimental study conducted in a Family Health Center in Ankara, with a single-center, stratified block randomization (parity: primiparous, multiparous; EPDS score: 0-9, 10-30).The number of pregnant women to be included in the study was calculated as 56.Personal Information Form, Prenatal Attachment Scale, Edinburgh Postpartum Depression Scale and Postpartum Attachment Scale will be used to collect data.
Detailed description
Sample Power analysis was performed to determine the number of samples. For this, the information in a similar study (Aydın Özkan et al., 2020) was used as a reference. The minimum number of participants required to be included in each group was determined as 24, with a total of 48 (α=0.01, 1-β=0.95). However, considering the loss rate (18.75%) in Aydın Özkan's study, which was taken as a reference, the total number of participants was determined as 56 (experimental: 28, control: 28).
Randomization In order to prevent imbalance between the groups, pregnant women will be assigned to the experimental and control groups by the tanned block randomization method. Pregnant women will be stratified according to parity (primiparous-multiparous) and Edinburgh Postpartum Depression Scale score (0-9 points, 10-30 points). In this context, 8 groups will be formed as shown below.
Set 1: Primiparous and pregnant women with EPDS scores between 0 and 9 Set 2: Primiparous and pregnant women with a EPDS score of 10-30 Set 3: Multiparous and pregnant women with EPDS score between 0 and 9 Set 4: Multiparous and pregnant women with a EPDS score of 10-30 Data Collection Personal Information Form, Prenatal Attachment Scale, Edinburgh Postpartum Depression Scale and Postpartum Attachment Scale will be used to collect data.
The purpose and content of the study will be explained by interviewing 35-week-old pregnant women who applied to FHCs for pregnancy follow-up. Their compliance with the sampling inclusion criteria will be evaluated. Then, an informed consent form will be signed by the pregnant women who agree to take part in the study. Personal information form, Prenatal Attachment Scale and Edinburgh Postpartum Depression Scale will be administered to pregnant women participating in the research. Then, the pregnant women will be randomized by stratified blocking according to their parity and EPDS score averages, and the assignment of the experimental and control groups will be made. Contact information (Phone numbers and e-mail addresses) will be taken at the first encounter.Experimental Group Application 36-37 with pregnant women in the experimental group. There will be a total of two online interviews, once a week, starting from the first week. Before the first interview, women will be sent a PKGE video explained by the researcher via e-mail or Whatsapp application, and they will be asked to watch it before the interview. In the first meeting, basic information about postpartum depression and what to do to prevent postpartum depression will be explained. The women will then be asked to describe the PKGE. The interview will be terminated when it is confirmed that the women have understood correctly and fully. Afterwards, "Relaxation Exercises CD Audio Recordings" belonging to the Turkish Psychological Association will be sent to the women, and they will be asked to do PCGE at least 3 days a week until delivery, accompanied by the instructions on the CD. In the second meeting; If postpartum depression develops, what should be done and maternal attachment will be explained, and women's opinions and questions about PCGE will be taken. In this interview, women will be asked to continue PCGE at least 3 days a week from the day they feel ready, starting at the latest 1 week after delivery.
During the application process to women, "Don't forget to do your relaxation exercise" every other day, "Weekdays to talk to your nurse about the training issues you have received. Weekend …. You can call or send a message about the issues you want to consult between the hours of the day. message will be sent. If the woman wants to have an interview, she will be called at the specified times and interviewed and the participant's questions will be answered. If it is noticed that an issue that needs help from different disciplines or that a postpartum complication develops, he will be referred to the hospital.
The Edinburgh Postpartum Depression Scale and the Postpartum Attachment Scale will be administered at the sixth week postpartum. The scales will be converted into an online questionnaire and mothers will be asked to fill in by sending their contact address.
Control group application Prenatal Attachment Scale and Edinburgh Postpartum Depression Scale will be administered to women at 35 weeks of pregnancy, Postpartum Attachment Scale and Edinburgh Postpartum Depression Scale will be administered to women at 6 weeks postpartum. The scales will be converted into an online questionnaire and women will be asked to fill in by sending their transportation address. No intervention will be applied to the women in the control group during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| experimental group application | Experimental | Behavioral: progressive muscle relaxation exerciseprogressive muscle relaxation exercise health education |
| control group application | No intervention | –No intervention will be made in the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Being at least literate
- Being at least 18-35 years old
- Being between 35-36 weeks of pregnancy
- Not having any psychiatric diagnosis
- Not being pregnant at risk
Key exclusion criteria (7 listed)
- Having a stillbirth
- Hospitalization of the newborn
- Hospitalization of the mother
- The woman's desire to leave the research
- Not filling out data collection tools
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 |
|---|---|---|
| progressive muscle relaxation exerciseAlso: health education36-37 with pregnant women in the experimental group. There will be two online interviews starting from week one. Before the first interview, the PMRE video will be sent to the women, explained by the researcher. In the first meeting, basic information about postpartum depression and what to do to prevent postpartum depression and its treatment will be explained. The women will then be asked to describe the PKGE. "Relaxation Exercises CD Audio Recordings" belonging to the Turkish Psychological Association will be sent to women, and they will be asked to perform PMRE at least 3 days a week until delivery, accompanied by the instructions on the CD. In the second meeting; maternal attachment will be explained. In this interview, women will be asked to continue to do PMRE at least 3 days a week from the day they feel ready, starting at the latest 1 week after delivery. | Behavioural | experimental group application |
Primary outcome
The Edinburgh Postpartum Depression Scale (EPDS), Prenatal Attachment Scale (PAS)
Time frame: prenatal 35. week
PAS and EPDS will be administered to women at 35 weeks of pregnancy.The scales will be converted into an online questionnaire and mothers will be asked to fill in by sending their contact address. The lowest score that can be obtained from EPDS is 0 and the highest score is 30.Women with a total scale score higher than the cut-off point are considered to be a risk group in terms of postpartum depression.A minimum of 21 points and a maximum of 84 points can be obtained from the PBE. The increase in the score obtained by the pregnant indicates that the level of attachment also increases.
1 secondary outcome
The EPDS, The Postpartum Attachment Scale (PPAS)
Time frame: postpartum 6. week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
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.
Şengül Yaman Sözbir, Assoc. principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive muscle relaxation exercise in people with Postpartum Depression and Progressive Muscle Relaxation, run by Gazi 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CANAN UÇAKCI ASALIOĞLU, MD (31202162685 ext. 90, cananucakci@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Edinburgh Postpartum Depression Scale (EPDS), Prenatal Attachment Scale (PAS) (time frame: prenatal 35. week). 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 14 Apr 2022.