AttachmentNCT05489861
The Effect of Affirmation and Massage on Babies
A study testing M-AM and F-AM in people with Attachment and Mother-Infant Interaction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical Center in Istanbul, on the sleep quality of their infants and mother-father-infant… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Attachment, Mother-Infant Interaction, Sleep Quality
- What is being tested?
- M-AM and F-AM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy infants
- Non-pregnant mothers
- Mothers and fathers who agree to participate in the study
- Who do not have communication problems
- Who does not have a chronic and mental disease
Who cannot join
- Babies with any disease
- Diagnosed with sleep a disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Affirmation and Massage on Babies on Sleep Quality and Maternal-Paternal Attachment: Randomized Controlled Experimental Study
The research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical Center in Istanbul, on the sleep quality of their infants and mother-father-infant attachment. The research will be carried out between August and October 2022 by including the parents of the babies in the scope of the study. The Mother-Father and Infant Information Form and the Extended Infant Short Sleep Questionnaire, the Maternal Attachment Scale, and the Father-Infant Attachment Scale will be used to collect the data.
Read the detailed description
This study was designed as a randomized controlled experimental study with the aim of examining the effect of affirmation and massage applied by mothers and fathers to their infants on their infants' sleep quality and maternal-paternal attachment. Infants aged 0-6 months will be included in the study. In the study, 15 babies (d=0.80, G=0.80, p=0.05) will be randomly selected for each group, Experimental Group 1: The Group To which the Mother Applies Affirmation and Massage (A), Experimental Group 2: The Group To which the Father Applies Affirmation and Massage (B) and Control Group (C) will be determined as three groups. Some criteria will be considered in infants selected and not selected into groups.
Experimental Group 1: Mothers in Group (A) Affirmation and Massage, Experimental Group 2: Fathers in Group (B) Affirmation and Massage, 3 days a week for 15 minutes, will be taught to apply affirmation and massage. Affirmation and massage applications will be shown once in the practice hall of the center as an example for the mother and father to be applied to their baby. Afterwards, affirmation and massage applications will be applied by the mother and father at the baby's home. After 5 weeks, the experimental and control groups will be invited to the center and the results will be compared by measuring with the data collection tools again.
- Conditions
- Attachment, Mother-Infant Interaction, Sleep Quality
- Being tested
- M-AM, F-AM
- Keywords
- Baby massage, mother-baby attachment, father-baby attachment, affirmation, sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-AMBehavioural
To examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment.
F-AMBehavioural
To examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A The Group to which the Mother Applies Affirmation and Massage | Experimental | 15 minutes of affirmation and massage practices, 3 days a week for 5 weeks, will be taught.
Affirmation and massage practices will be shown once in the practice hall of the center as an example for the mother to apply to their baby.
Afterward, affirmation and massage applications will be applied by the mother and father at the baby's home.
Parents will be informed about the importance of having the same characteristics of the practice room for each application.
In addition, the massage video material will be given to the mother with an affirmation note as a reminder. Receives: Behavioral: M-AM |
| Experimental group B The Group to which the Father Applies Affirmation and Massage | Experimental | 15 minutes of affirmation and massage practices, 3 days a week for 5 weeks, will be taught.
Affirmation and massage practices will be shown once in the practice hall of the center as an example for the father to apply to their baby.
Afterward, affirmation and massage applications will be applied by the mother and father at the baby's home.
Parents will be informed about the importance of having the same characteristics of the practice room for each application.
In addition, the massage video material will be given to the father with an affirmation note as a reminder. Receives: Behavioral: F-AM |
| Control Group (C) | No intervention | Parents will be asked to continue the implementation of routine sleeping techniques without being taught any practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examining the infant's sleep quality of infant massage and affirmation
The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. The survey has no minimum and maximum points. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.
Measured: 1. week
Examining the infant's sleep quality of infant massage and affirmation
The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. It will apply to both mothers and fathers. This scale does not have a score. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.
Measured: 5. week
Effect on maternal attachment
The Maternal Attachment Inventory will be used. At the beginning and end of the research. Cronbach's alpha values are 0.77 in the first month and 0.82 in the 4th month for mothers. It will only apply to mothers. It is a 26-item scale. this scale's high point is 104 and the low point is 98. A high score on the scale indicates high maternal attachment.
Measured: 1. weeks
Effect on maternal attachment
The Maternal Attachment Inventory will be used. At the beginning and end of the research. Cronbach's alpha values are 0.77 in the first month and 0.82 in the 4th month for mothers. It will only apply to mothers. It is a 26-item scale. this scale's high point is 104 and the low point is 98. A high score on the scale indicates high maternal attachment
Measured: 5. weeks
Effect on paternal attachment
The paternal-infant attachment scale will be used. At the beginning and end of the research. Higher scores indicate higher attachment. It will only apply to fathers. It is a 19-item scale. Each item of the scale is scored between one and five points. this scale's high point is 90 and the low point is 18. Higher scores indicate higher attachment.
Measured: 1. week
Effect on paternal attachment
The paternal-infant attachment scale will be used. At the beginning and end of the research. It will only apply to fathers. It is a 19-item scale. this scale's high point is 90 and the low point is 18. Each item of the scale is scored between one and five points. Higher scores indicate higher attachment.
Measured: 5. weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttachmentStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Şener Özovalı, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489861
- Sponsor's protocol ID
- IstanbulUC-NilaySener
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2022
- Last updated
- 5 Aug 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 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Affirmation and Massage on Babies on Sleep Quality and Maternal-Paternal Attachment: Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05489861
- Acronym / sponsor ID
- IstanbulUC-NilaySener
- Conditions
- Attachment, Mother-Infant Interaction, Sleep Quality
- Keywords
- Baby massage, mother-baby attachment, father-baby attachment, affirmation, sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 5 Aug 2022 (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 research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical Center in Istanbul, on the sleep quality of their infants and mother-father-infant attachment. The research will be carried out between August and October 2022 by including the parents of the babies in the scope of the study. The Mother-Father and Infant Information Form and the Extended Infant Short Sleep Questionnaire, the Maternal Attachment Scale, and the Father-Infant Attachment Scale will be used to collect the data.
Detailed description
This study was designed as a randomized controlled experimental study with the aim of examining the effect of affirmation and massage applied by mothers and fathers to their infants on their infants' sleep quality and maternal-paternal attachment. Infants aged 0-6 months will be included in the study. In the study, 15 babies (d=0.80, G=0.80, p=0.05) will be randomly selected for each group, Experimental Group 1: The Group To which the Mother Applies Affirmation and Massage (A), Experimental Group 2: The Group To which the Father Applies Affirmation and Massage (B) and Control Group (C) will be determined as three groups. Some criteria will be considered in infants selected and not selected into groups.
Experimental Group 1: Mothers in Group (A) Affirmation and Massage, Experimental Group 2: Fathers in Group (B) Affirmation and Massage, 3 days a week for 15 minutes, will be taught to apply affirmation and massage. Affirmation and massage applications will be shown once in the practice hall of the center as an example for the mother and father to be applied to their baby. Afterwards, affirmation and massage applications will be applied by the mother and father at the baby's home. After 5 weeks, the experimental and control groups will be invited to the center and the results will be compared by measuring with the data collection tools again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group A The Group to which the Mother Applies Affirmation and Massage | Experimental | Behavioral: M-AM15 minutes of affirmation and massage practices, 3 days a week for 5 weeks, will be taught. Affirmation and massage practices will be shown once in the practice hall of the center as an example for the mother to apply to their baby. Afterward, affirmation and massage applications will be applied by the mother and father at the baby's home. Parents will be informed about the importance of having the same characteristics of the practice room for each application. In addition, the massage video material will be given to the mother with an affirmation note as a reminder. |
| Experimental group B The Group to which the Father Applies Affirmation and Massage | Experimental | Behavioral: F-AM15 minutes of affirmation and massage practices, 3 days a week for 5 weeks, will be taught. Affirmation and massage practices will be shown once in the practice hall of the center as an example for the father to apply to their baby. Afterward, affirmation and massage applications will be applied by the mother and father at the baby's home. Parents will be informed about the importance of having the same characteristics of the practice room for each application. In addition, the massage video material will be given to the father with an affirmation note as a reminder. |
| Control Group (C) | No intervention | –Parents will be asked to continue the implementation of routine sleeping techniques without being taught any practices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy infants
- Non-pregnant mothers
- Mothers and fathers who agree to participate in the study
- Who do not have communication problems
- Who does not have a chronic and mental disease
Key exclusion criteria (2 listed)
- Babies with any disease
- Diagnosed with sleep a disorder
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 |
|---|---|---|
| M-AMTo examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment. | Behavioural | Experimental group A The Group to which the Mother Applies Affirmation and Massage |
| F-AMTo examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment. | Behavioural | Experimental group B The Group to which the Father Applies Affirmation and Massage |
Primary outcome
Examining the infant's sleep quality of infant massage and affirmation
Time frame: 1. week
The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. The survey has no minimum and maximum points. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.
Examining the infant's sleep quality of infant massage and affirmation
Time frame: 5. week
The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. It will apply to both mothers and fathers. This scale does not have a score. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.
Effect on maternal attachment
Time frame: 1. weeks
The Maternal Attachment Inventory will be used. At the beginning and end of the research. Cronbach's alpha values are 0.77 in the first month and 0.82 in the 4th month for mothers. It will only apply to mothers. It is a 26-item scale. this scale's high point is 104 and the low point is 98. A high score on the scale indicates high maternal attachment.
Effect on maternal attachment
Time frame: 5. weeks
The Maternal Attachment Inventory will be used. At the beginning and end of the research. Cronbach's alpha values are 0.77 in the first month and 0.82 in the 4th month for mothers. It will only apply to mothers. It is a 26-item scale. this scale's high point is 104 and the low point is 98. A high score on the scale indicates high maternal attachment
Effect on paternal attachment
Time frame: 1. week
The paternal-infant attachment scale will be used. At the beginning and end of the research. Higher scores indicate higher attachment. It will only apply to fathers. It is a 19-item scale. Each item of the scale is scored between one and five points. this scale's high point is 90 and the low point is 18. Higher scores indicate higher attachment.
Effect on paternal attachment
Time frame: 5. weeks
The paternal-infant attachment scale will be used. At the beginning and end of the research. It will only apply to fathers. It is a 19-item scale. this scale's high point is 90 and the low point is 18. Each item of the scale is scored between one and five points. Higher scores indicate higher attachment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Attachment
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Not yet recruiting
Integrated Attachment Theory
Attachment Disorder
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
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 M-AM and F-AM in people with Attachment and Mother-Infant Interaction, run by Istanbul University - Cerrahpasa 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 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 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?
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?
Examining the infant's sleep quality of infant massage and affirmation (time frame: 1. week). The study lists 6 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 5 Aug 2022.