Postpartum SadnessNCT06293274
The Importance of Discharge Education for Mommy Blues
A study testing Discharge training in people with Postpartum Sadness, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province. The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Sadness
- What is being tested?
- Discharge training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 May 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 38-42. Those who gave birth between weeks of gestation,
- Those who have had vaginal birth or caesarean section,
- Able to speak and understand Turkish,
- Those over 18 years of age,
- Mothers with a single healthy baby
- Those with an Edinburgh Postnatal Depression Scale score of 9 or less in depressive symptoms screening
Who cannot join
- Preterm or postterm birth,
- Received psychiatric treatment or used psychotropic medications during pregnancy,
- Having a history of substance dependence and/or use in the past 6 months,
- Being in the high-risk category,
- Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver),
- Mothers having babies with congenital malformations requiring intensive care intervention (small for gestational age, mort de fetus, fetus without major pathology according to ultrasonography).
- Participants who wish to withdraw from the study at any time will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Discharge Education on Maternity Blues and Postpartum Depression
The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.
The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.
Read the detailed description
The purpose of this study is to determine the effect of discharge training on maternal sadness and postpartum depression on the level of maternal sadness and postpartum depression in the puerperium follow-up. In this context, the hypotheses of the study are as follows;
Hypothesis 1:
H0: There is no difference in the total scores of the Maternal Sadness Scale used in the postpartum follow-up of mothers who received discharge training on maternal sadness and postpartum depression and mothers who did not receive training.
H1: There will be a difference in the total scores of the Maternal Sadness Scale used in the postpartum follow-up of mothers who received discharge education on maternal sadness and postpartum depression and mothers who did not receive education.
Hypothesis 2:
H0: There will be no difference in total scores on the Edinburgh Postpartum Depression Scale used in the postpartum follow-up of mothers who received discharge education on maternal grief and postpartum depression and mothers who did not receive education.
H1: There is a difference in the total scores of the Edinburgh Postpartum Depression Scale used in the postpartum follow-up of mothers who received discharge education on maternal grief and postpartum depression and mothers who did not receive education.
Mothers enrolled in the study will be randomly assigned to groups, and homogeneity in the distribution of groups will be ensured. "Random Allocation Software Program will be used to randomly assign mothers to groups, and a randomization list for the study will be generated by determining the number and group number of each participant.
Postpartum women to be included in the study will be assigned to one of the routine discharge training and discharge education groups by the researcher according to the order in the randomization list. Only that mother will be studied until the mother assigned to the randomization group has been informed about the research and has completed the necessary training compared to the routine discharge training/discharge education group. After the mother's research process is completed, another mother who has been admitted to the ward and meets the research criteria will be assigned to the other group on the randomization list and the necessary practices will be carried out. If the mother leaves the study for any reason during the study, the first mother admitted to the ward who meets the research criteria will be assigned to the other group on the randomization list.
In a randomized controlled trial with discharge education and routine discharge training groups, after the research groups are formed; In the first phase, the participants assigned to the discharge education group will be given a discharge education on postpartum depression and motherhood blues through a face-to-face interview technique and a "personal information form" will be used. It is expected that the discharge training and data collection will take approximately 15-20 minutes. After the training, an information booklet prepared by the researchers after a literature review will be given to the participants in print, via email or WhatsApp, depending on the researcher's preference. 5-7 days of postpartum period after the mothers are discharged. On these days, the researcher will call you and inform you that the 32-item Motherhood Sadness Scale will be administered. Data collection is expected to take approximately 5-10 minutes. Interviewed mothers will be contacted by the researcher by telephone at 6 weeks postpartum after discharge from the hospital and informed that the 10-item Edinburgh Postpartum Depression Scale will be administered. Data collection is expected to take approximately 5 minutes.
After the scale data are collected during the interview, the researcher will provide brief verbal information about the Motherhood Blues Scale and the Edinburgh Postpartum Depression Scale scores, and mothers whose scale scores are determined to be high will be referred to the necessary units to increase necessary psychiatric counseling and social support.
The mother assigned to the routine discharge training group will receive routine hospital discharge education. Then the "Personal Information Form" will be used. The mother whose contact information was collected will be examined by the researcher on the 5th-7th day of her postpartum period after her discharge. On these days, the researcher will call you and inform you that the 32-item "Motherhood Sadness Scale" will be administered. Data collection is expected to take approximately 5-10 minutes. Interviewed mothers will be contacted by the researcher by telephone at 6 weeks postpartum after discharge from the hospital and informed that the 10-item Edinburgh Postpartum Depression Scale will be administered. Data collection is expected to take approximately 5 minutes. After the scale data have been collected during the interview, the researcher will provide brief verbal information about the Motherhood Blues Scale and Edinburgh Postpartum Depression Scale scores, and mothers whose scale scores are determined to be high will be referred to the necessary services to enhance necessary psychiatric care and social support.
- Conditions
- Postpartum Sadness
- Being tested
- Discharge training
- Keywords
- discharge, maternity, sadness, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge trainingProcedure or surgery
Also called motherhood blues education
What is motherhood blues? Why does it occur? What are its symptoms? How to deal with it? What is postpartum depression? What causes postpartum depression? Information is provided on this topic.
| Study group | Role | What they receive |
|---|---|---|
| Discharge education | Experimental | Participants assigned to the discharge education group will receive discharge education about postpartum blues and postpartum depression. A "Personal Information Form" will be used. Discharge training and data collection are expected to take approximately 15-20 minutes. 5-7 days postpartum after the mothers are discharged. The 32-item "Motherhood Sadness Scale" will be administered by the researcher by telephone during the following days. In the 6th week of the postpartum period, the mothers will be contacted by the researcher by telephone and the 10-item "Edinburgh Postpartum Depression Scale" will be administered. Receives: Procedure: Discharge training |
| Routine discharge training | No intervention | Participants assigned to the routine discharge training group will receive routine discharge training. "A personal information form will be used. Discharge training and data collection are expected to take approximately 15-20 minutes. 5-7 days postpartum after mothers are discharged. The 32-item "Motherhood Sadness Scale" will be administered by the researcher by telephone during the following days. In the 6th week of the postpartum period, the mothers will be contacted by the researcher by telephone and the 10-item "Edinburgh Postpartum Depression Scale" will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motherhood Sadness Scale
The scale developed to evaluate motherhood blues consists of 32 items and 8 sub-dimensions. These sub-dimensions; skin-to-skin contact, communication, staying in the same room, breastfeeding, physical adaptation, responsibility, culture, economic factors, information and economic support, social support. Scale items contain positive and negative expressions. The scale is graded as 'completely appropriate (5 points), appropriate (4 points), rarely appropriate (3 points), not appropriate (2 points), not at all appropriate (1 point). The minimum score that can be obtained from the scale is 32 and the maximum score is 160. A high total score in the evaluation of the scale indicates experiencing motherhood blues.
Measured: 5-7 days of the postpartum period after the mother's discharge. It will be obtained by the researcher by telephone on the following days.
Edinburgh Postnatal Depression Scale - EPDS
The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0 and the highest score is 30. Although the cut-off scores for the scale vary between studies, it is stated that a cut-off score of 12 may be sufficient to determine clinical depression. The scale is a screening scale to determine the risk of postpartum depression.
Measured: At 6 weeks postpartum, the researcher will call and administer the 10-item Edinburg Postpartum Depression Scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum SadnessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sena dilek, Kocaeli University
- Investigators
- Sena Dilek Aksoy, Ph.D., Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293274
- Sponsor's protocol ID
- sdilek5
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Y, Li Y, Wang J, Chen Q, Bazzano AN, Cao F. Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 27;23(1):e23410. doi: 10.2196/23410.
PubMed 33502326
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discharge Education on Maternity Blues and Postpartum Depression
- ClinicalTrials.gov ID
- NCT06293274
- Acronym / sponsor ID
- sdilek5
- Conditions
- Postpartum Sadness
- Keywords
- discharge, maternity, sadness, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 5 Mar 2024 (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.
The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.
The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.
Detailed description
The purpose of this study is to determine the effect of discharge training on maternal sadness and postpartum depression on the level of maternal sadness and postpartum depression in the puerperium follow-up. In this context, the hypotheses of the study are as follows;
Hypothesis 1:
H0: There is no difference in the total scores of the Maternal Sadness Scale used in the postpartum follow-up of mothers who received discharge training on maternal sadness and postpartum depression and mothers who did not receive training.
H1: There will be a difference in the total scores of the Maternal Sadness Scale used in the postpartum follow-up of mothers who received discharge education on maternal sadness and postpartum depression and mothers who did not receive education.
Hypothesis 2:
H0: There will be no difference in total scores on the Edinburgh Postpartum Depression Scale used in the postpartum follow-up of mothers who received discharge education on maternal grief and postpartum depression and mothers who did not receive education.
H1: There is a difference in the total scores of the Edinburgh Postpartum Depression Scale used in the postpartum follow-up of mothers who received discharge education on maternal grief and postpartum depression and mothers who did not receive education.
Mothers enrolled in the study will be randomly assigned to groups, and homogeneity in the distribution of groups will be ensured. "Random Allocation Software Program will be used to randomly assign mothers to groups, and a randomization list for the study will be generated by determining the number and group number of each participant.
Postpartum women to be included in the study will be assigned to one of the routine discharge training and discharge education groups by the researcher according to the order in the randomization list. Only that mother will be studied until the mother assigned to the randomization group has been informed about the research and has completed the necessary training compared to the routine discharge training/discharge education group. After the mother's research process is completed, another mother who has been admitted to the ward and meets the research criteria will be assigned to the other group on the randomization list and the necessary practices will be carried out. If the mother leaves the study for any reason during the study, the first mother admitted to the ward who meets the research criteria will be assigned to the other group on the randomization list.
In a randomized controlled trial with discharge education and routine discharge training groups, after the research groups are formed; In the first phase, the participants assigned to the discharge education group will be given a discharge education on postpartum depression and motherhood blues through a face-to-face interview technique and a "personal information form" will be used. It is expected that the discharge training and data collection will take approximately 15-20 minutes. After the training, an information booklet prepared by the researchers after a literature review will be given to the participants in print, via email or WhatsApp, depending on the researcher's preference. 5-7 days of postpartum period after the mothers are discharged. On these days, the researcher will call you and inform you that the 32-item Motherhood Sadness Scale will be administered. Data collection is expected to take approximately 5-10 minutes. Interviewed mothers will be contacted by the researcher by telephone at 6 weeks postpartum after discharge from the hospital and informed that the 10-item Edinburgh Postpartum Depression Scale will be administered. Data collection is expected to take approximately 5 minutes.
After the scale data are collected during the interview, the researcher will provide brief verbal information about the Motherhood Blues Scale and the Edinburgh Postpartum Depression Scale scores, and mothers whose scale scores are determined to be high will be referred to the necessary units to increase necessary psychiatric counseling and social support.
The mother assigned to the routine discharge training group will receive routine hospital discharge education. Then the "Personal Information Form" will be used. The mother whose contact information was collected will be examined by the researcher on the 5th-7th day of her postpartum period after her discharge. On these days, the researcher will call you and inform you that the 32-item "Motherhood Sadness Scale" will be administered. Data collection is expected to take approximately 5-10 minutes. Interviewed mothers will be contacted by the researcher by telephone at 6 weeks postpartum after discharge from the hospital and informed that the 10-item Edinburgh Postpartum Depression Scale will be administered. Data collection is expected to take approximately 5 minutes. After the scale data have been collected during the interview, the researcher will provide brief verbal information about the Motherhood Blues Scale and Edinburgh Postpartum Depression Scale scores, and mothers whose scale scores are determined to be high will be referred to the necessary services to enhance necessary psychiatric care and social support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discharge education | Experimental | Procedure: Discharge trainingParticipants assigned to the discharge education group will receive discharge education about postpartum blues and postpartum depression. A "Personal Information Form" will be used. Discharge training and data collection are expected to take approximately 15-20 minutes. 5-7 days postpartum after the mothers are discharged. The 32-item "Motherhood Sadness Scale" will be administered by the researcher by telephone during the following days. In the 6th week of the postpartum period, the mothers will be contacted by the researcher by telephone and the 10-item "Edinburgh Postpartum Depression Scale" will be administered. |
| Routine discharge training | No intervention | –Participants assigned to the routine discharge training group will receive routine discharge training. "A personal information form will be used. Discharge training and data collection are expected to take approximately 15-20 minutes. 5-7 days postpartum after mothers are discharged. The 32-item "Motherhood Sadness Scale" will be administered by the researcher by telephone during the following days. In the 6th week of the postpartum period, the mothers will be contacted by the researcher by telephone and the 10-item "Edinburgh Postpartum Depression Scale" will be administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 38-42. Those who gave birth between weeks of gestation,
- Those who have had vaginal birth or caesarean section,
- Able to speak and understand Turkish,
- Those over 18 years of age,
- Mothers with a single healthy baby
Key exclusion criteria (7 listed)
- Preterm or postterm birth,
- Received psychiatric treatment or used psychotropic medications during pregnancy,
- Having a history of substance dependence and/or use in the past 6 months,
- Being in the high-risk category,
- Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver),
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 |
|---|---|---|
| Discharge trainingAlso: motherhood blues educationWhat is motherhood blues? Why does it occur? What are its symptoms? How to deal with it? What is postpartum depression? What causes postpartum depression? Information is provided on this topic. | Procedure or surgery | Discharge education |
Primary outcome
Motherhood Sadness Scale
Time frame: 5-7 days of the postpartum period after the mother's discharge. It will be obtained by the researcher by telephone on the following days.
The scale developed to evaluate motherhood blues consists of 32 items and 8 sub-dimensions. These sub-dimensions; skin-to-skin contact, communication, staying in the same room, breastfeeding, physical adaptation, responsibility, culture, economic factors, information and economic support, social support. Scale items contain positive and negative expressions. The scale is graded as 'completely appropriate (5 points), appropriate (4 points), rarely appropriate (3 points), not appropriate (2 points), not at all appropriate (1 point). The minimum score that can be obtained from the scale is 32 and the maximum score is 160. A high total score in the evaluation of the scale indicates experiencing motherhood blues.
Edinburgh Postnatal Depression Scale - EPDS
Time frame: At 6 weeks postpartum, the researcher will call and administer the 10-item Edinburg Postpartum Depression Scale.
The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0 and the highest score is 30. Although the cut-off scores for the scale vary between studies, it is stated that a cut-off score of 12 may be sufficient to determine clinical depression. The scale is a screening scale to determine the risk of postpartum depression.
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 21 Jun 2024.
- Background: PubMed 33502326Sun Y, Li Y, Wang J, Chen Q, Bazzano AN, Cao F. Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 27;23(1):e23410. doi: 10.2196/23410.
Related trials for Postpartum Sadness
Recruiting
Investigation of TVNS Administration on Postpartum Mental Health
Postpartum Depression (PPD), Postpartum Anxiety
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.
Sena Dilek Aksoy, Ph.D. study director
Kocaeli 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 Discharge training in people with Postpartum Sadness, run by Kocaeli 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 6 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: finished, as of the sponsor's last update on 21 Jun 2024. 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?
Motherhood Sadness Scale (time frame: 5-7 days of the postpartum period after the mother's discharge. It will be obtained by the researcher by telephone on the following days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293274, which also lists 1 linked publication.
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 21 Jun 2024.