Postpartum PeriodNCT06475885
Effect of Baby Massage on Postnatal Maternal Attachment and Depression
A study testing Infant Massage Program in people with Postpartum Period, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of providing infant massage training to mothers in the early postpartum period with the goal of preventing postpartum depression and enhancing maternal bonding. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Infant Massage Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2022to 18 Jun 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primiparous
- Singleton pregnancy
- Delivery at term (37-42 weeks of gestation)
- Edinburgh Postnatal Depression Scale score ≤ 12
- No physical health issues preventing massage
- No history of psychiatric illness (self-reported)
Show all 11Show fewer
- At least basic literacy
- Residing in Ankara
- No previous training in infant massage
- Speaking the same language as the researcher
- Absence of any anomaly, malformation, or health issue preventing massage (for infants)
Who cannot join
- Not having completed the infant massage training
- Wanting to withdraw from the study for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Baby Massage on Postnatal Maternal Attachment and Depression: Randomized Controlled Study
This study aims to examine the effects of providing infant massage training to mothers in the early postpartum period with the goal of preventing postpartum depression and enhancing maternal bonding.
Read the detailed description
Postpartum depression is a common and serious mood disorder influenced by various factors. The global prevalence of postpartum depression has been identified as 17.22%. Depressive symptoms experienced by the mother can affect her daily activities and have a negative impact on infant care. Postpartum depression can also affect mother-infant bonding. A healthy bond between the mother and the baby supports the baby in feeling secure, emotionally satisfied, and adapting to the world. Infant massage has been encouraged in recent years for mothers as it can create positive effects on both depression and maternal attachment. This study provided infant massage training to mothers in the early postpartum period with the aim of preventing postpartum depression and enhancing maternal attachment. The Edinburgh Postnatal Depression Scale (EPDS) was administered to participants on the 14th day postpartum, and those with a score of 12 or below were included in the study. A total of 70 participants were randomly assigned to either the experimental group (35 participants) or the control group (35 participants). The experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum. The control group did not receive any training or intervention. At the end of the 5 weeks, participants were assessed using the Edinburgh Postnatal Depression Scale and the Maternal Attachment Inventory. The study examined whether there were differences in the mean scores of the scales between the groups.
- Conditions
- Postpartum Period
- Being tested
- Infant Massage Program
- Keywords
- Depression, Postpartum, Attachment, Massage, Infant, Nursing
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Massage ProgramOther
The experimental group received the International Association of Infant Massage (IAIM) Infant Massage Program starting from day 14 postpartum for a duration of 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group Receiving Infant Massage Training | Experimental | The experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum. Receives: Other: Infant Massage Program |
| Infant massage training not provided group | No intervention | The control group received no training or intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item measure used as a screening tool to identify the risk of depression, but it is not intended for diagnostic purposes. Each question on the scale is scored from 0 to 3, with the maximum possible score being 30. The 1st, 2nd, and 4th questions are scored 0-1-2-3, while the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th questions are scored 3-2-1-0. The cut-off point for the scale is 13, with scores of 13 and above indicating the presence of depression. In this study, the scale was administered to participants on the 14th and 45th days postpartum. The difference between the mean scores of the Edinburgh Postnatal Depression Scale in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p<0.05 indicates significance).
Measured: One month
Maternal Attachment Scale
The Maternal Attachment Inventory (MAI) is a unidimensional scale designed to measure the attachment between a mother and her baby. It consists of 26 items, each rated on a 4-point Likert scale ranging from "always" to "never." The scale is scored as follows: "Always = 4 points," "Frequently = 3 points," "Sometimes = 2 points," and "Never = 1 point." Higher total scores indicate higher levels of maternal attachment. The minimum possible score on the scale is 26, and the maximum possible score is 104. In this study, the scale was administered to participants on the 45th day postpartum. The difference between the mean scores of the Maternal Attachment Inventory in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p<0.05 indicates significance).
Measured: one day
he relationship between the Edinburgh Postnatal Depression Scale and Maternal Attachment Scale.
The relationship between the mean scores of the Edinburgh Postnatal Depression Scale and the mean scores of the Maternal Attachment Scale administered to participants on the 45th day postpartum was examined to determine if it is statistically significant (p<0.05 indicates significance).
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start25 Dec 2022
- Primary completion18 Jun 2023
- Study completion18 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparative study of two groups compared with a control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyda SARPER ERKILIC, Gazi University
- Investigators
- Ceyda Sarper-Erkılıç, Principal investigator, Gazi UniversityAyten Şentürk-Erenel, Principal investigator, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475885
- Sponsor's protocol ID
- GaziU-CSE-01
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baby Massage on Postnatal Maternal Attachment and Depression: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06475885
- Acronym / sponsor ID
- GaziU-CSE-01
- Conditions
- Postpartum Period
- Keywords
- Depression, Postpartum, Attachment, Massage, Infant, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 26 Jun 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.
This study aims to examine the effects of providing infant massage training to mothers in the early postpartum period with the goal of preventing postpartum depression and enhancing maternal bonding.
Detailed description
Postpartum depression is a common and serious mood disorder influenced by various factors. The global prevalence of postpartum depression has been identified as 17.22%. Depressive symptoms experienced by the mother can affect her daily activities and have a negative impact on infant care. Postpartum depression can also affect mother-infant bonding. A healthy bond between the mother and the baby supports the baby in feeling secure, emotionally satisfied, and adapting to the world. Infant massage has been encouraged in recent years for mothers as it can create positive effects on both depression and maternal attachment. This study provided infant massage training to mothers in the early postpartum period with the aim of preventing postpartum depression and enhancing maternal attachment. The Edinburgh Postnatal Depression Scale (EPDS) was administered to participants on the 14th day postpartum, and those with a score of 12 or below were included in the study. A total of 70 participants were randomly assigned to either the experimental group (35 participants) or the control group (35 participants). The experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum. The control group did not receive any training or intervention. At the end of the 5 weeks, participants were assessed using the Edinburgh Postnatal Depression Scale and the Maternal Attachment Inventory. The study examined whether there were differences in the mean scores of the scales between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A comparative study of two groups compared with a control group.
| Arm | Type | Receives |
|---|---|---|
| Group Receiving Infant Massage Training | Experimental | Other: Infant Massage ProgramThe experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum. |
| Infant massage training not provided group | No intervention | –The control group received no training or intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Primiparous
- Singleton pregnancy
- Delivery at term (37-42 weeks of gestation)
- Edinburgh Postnatal Depression Scale score ≤ 12
- No physical health issues preventing massage
Key exclusion criteria (2 listed)
- Not having completed the infant massage training
- Wanting to withdraw from the study for any reason
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 |
|---|---|---|
| Infant Massage ProgramThe experimental group received the International Association of Infant Massage (IAIM) Infant Massage Program starting from day 14 postpartum for a duration of 5 weeks. | Other | Group Receiving Infant Massage Training |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: One month
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item measure used as a screening tool to identify the risk of depression, but it is not intended for diagnostic purposes. Each question on the scale is scored from 0 to 3, with the maximum possible score being 30. The 1st, 2nd, and 4th questions are scored 0-1-2-3, while the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th questions are scored 3-2-1-0. The cut-off point for the scale is 13, with scores of 13 and above indicating the presence of depression. In this study, the scale was administered to participants on the 14th and 45th days postpartum. The difference between the mean scores of the Edinburgh Postnatal Depression Scale in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p<0.05 indicates significance).
Maternal Attachment Scale
Time frame: one day
The Maternal Attachment Inventory (MAI) is a unidimensional scale designed to measure the attachment between a mother and her baby. It consists of 26 items, each rated on a 4-point Likert scale ranging from "always" to "never." The scale is scored as follows: "Always = 4 points," "Frequently = 3 points," "Sometimes = 2 points," and "Never = 1 point." Higher total scores indicate higher levels of maternal attachment. The minimum possible score on the scale is 26, and the maximum possible score is 104. In this study, the scale was administered to participants on the 45th day postpartum. The difference between the mean scores of the Maternal Attachment Inventory in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p<0.05 indicates significance).
he relationship between the Edinburgh Postnatal Depression Scale and Maternal Attachment Scale.
Time frame: one day
The relationship between the mean scores of the Edinburgh Postnatal Depression Scale and the mean scores of the Maternal Attachment Scale administered to participants on the 45th day postpartum was examined to determine if it is statistically significant (p<0.05 indicates significance).
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 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ceyda Sarper-Erkılıç principal investigator
Gazi University
Ayten Şentürk-Erenel principal investigator
Lokman Hekim 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 Infant Massage Program in people with Postpartum Period, 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 11 inclusion and 2 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 26 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?
Edinburgh Postnatal Depression Scale (time frame: One month). The study lists 3 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 26 Jun 2024.