- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05676996
Investigation of the Effect of Attachment-Based Support Given in the Perinatal Period
Investigation of the Effect of Attachment-Based Support Given in the Perinatal Period on Prenatal Bonding, Early Mother-Infant Bonding Indicators and Maternal Bonding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sakarya, Turkey, 54050
- Sakarya University Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
be 19 years or older 21 and 26. Primigravida at gestational week Having had a normal delivery Watching all the videos within the scope of Attachment-Based Support Program by the pregnant women in the intervention group Being literate Pregnancy with only one baby The baby is at term Being the mother of the primary caregiver Volunteering to participate in the research The absence of any health problems of the mother and the baby Absence of a physician-diagnosed psychiatric disease in the mother Having a smart phone and wireless internet Pregnant women who answered "No" to Question 34 on the Pregnant Introductory Information Form and did not get a full score from the "Maternal Antenatal Attachment Scale"
Exclusion Criteria:
- The development of a situation that prevents the mother from participating in education during pregnancy
- Unwillingness to continue working
- A situation that prevents the mother and baby from staying in the same room in the postpartum period
- Severe trauma or loss of the mother during pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: attachment-based support group
In addition to the routine follow-ups and trainings that the pregnant women in the intervention group can receive from the hospital, they will be included in the "Attachment Based Support Program".
Within the scope of the 1st stage of this support; A mobile application.
There are 12 videos on connecting in the mobile application.
These videos were shot by the researcher in a professional studio.
22nd-26th of pregnancy.
The participants included in the study during the weeks of participation installed this mobile application on their phones during participation.
It was requested to complete watching the videos by 36 weeks.
In the second phase of Attachment-Based Support, breastfeeding and skin-to-skin contact support are provided to mothers on postpartum day 0.
|
attachment-based support application; It includes video-based trainings on attachment via mobile application and breastfeeding and skin-to-skin contact support for mothers on postpartum day 0.
|
|
No Intervention: routine follow-up control group
The control group pregnants were left to the routine follow-up of the hospitals during their pregnancy and postpartum period.
In this follow-up; When pregnant women apply to the outpatient clinic services of the hospital, appointments are made for their monthly routine follow-up.
Information and practices that support mother-infant attachment in attachment-based support modules are not included in these trainings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.
Time Frame: 22.-26. pre-test between weeks
|
prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus.
The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus).
A high score from the scale indicates a high degree of attachment.
|
22.-26. pre-test between weeks
|
|
Pregnant women who participated in the Attachment-Based Support Program during the perinatal period showed more early mother-infant attachment symptoms than those who did not.
Time Frame: this scale will be administered to mothers on postpartum day 0.
|
The scale of early mother-infant attachment indicators is an observational scale consisting of 13 items.
The lowest 0 and the highest 26 points are taken from the scale.
As the scores obtained from the scale increase, attachment increases.
|
this scale will be administered to mothers on postpartum day 0.
|
|
Pregnant women who participated in Attachment-Based Support Program in the perinatal period had higher maternal attachment than those who did not.
Time Frame: postpartum 1st month
|
The maternal attachment scale is a scale applied at the earliest postpartum 1st month.
The lowest score to be obtained from the scale varies between 26 and the highest score between 104.
A high score from the scale indicates a high level of maternal attachment.
|
postpartum 1st month
|
|
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.
Time Frame: post-test at 36 weeks
|
prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus.
The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus).
A high score from the scale indicates a high degree of attachment.
|
post-test at 36 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nursan CİNAR, PhD, Sakarya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Attachment-Based Support
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attachment Disorder
-
Inonu UniversityTuba UçarCompleted
-
University of MiamiRecruitingParent-Child Relations | Parenting | Attachment DisorderUnited States
-
University of Los Andes, ColumbiaGenesis FoundationCompletedParenting | Child Development | Attachment Disorder | Exposure to Violent EventColombia
-
Biruni UniversityCompletedAttachment DisorderTurkey
-
VIVE - The Danish Center for Social Science ResearchUniversity of Copenhagen; Anna Freud National Centre for Children and Families and other collaboratorsActive, not recruiting
-
Kahramanmaras Sutcu Imam UniversityCukurova UniversityCompletedPathernal Attachment | Effect of Education to Pathernal AttachmentTurkey
-
Western University, CanadaRecruitingCesarean Section Complications | Post Operative Recovery | Attachment DisorderCanada
-
Beykoz UniversityUskudar University; Istanbul Nisantasi UniversityRecruitingDepressive Disorder | Anxiety Disorders | Emotion Regulation | Attachment | Relationship DistressTurkey
-
Ondokuz Mayıs UniversityCompletedAnxiety | Pregnancy Related | Attachment DisorderTurkey
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedChild Development | Child Behavior Disorders | Reactive Attachment DisorderUnited States
Clinical Trials on attachment-based support
-
Pennsylvania Department of HealthChildren's Hospital of Philadelphia; University of Pittsburgh; Lehigh Valley...Terminated
-
Drexel UniversityUnknownBinge-Eating Disorder | Bulimia Nervosa | Other Specified Feeding or Eating DisorderUnited States
-
Inonu UniversityTuba UçarCompleted
-
University of DelawareSidney Kimmel Cancer Center at Thomas Jefferson University; Helen F. Graham...TerminatedAnxiety | Depressive Symptoms | Parental StressUnited States
-
Hospital Miguel ServetActive, not recruiting
-
University of ValenciaUnknownChronic Medical IllnessSpain
-
Universitat Jaume IEuropean Social Fund; Generalitat ValencianaCompletedCompassion | Mental Health Wellness 1Spain
-
LiquidGoldConceptUniversity of MichiganCompletedBreastfeeding | Patient Simulation | High Fidelity Simulation TrainingUnited States
-
Helse Stavanger HFThe Research Council of NorwayTerminatedDepressive Disorder | Major Depression | Mood DisorderNorway
-
Children's Hospital of PhiladelphiaCompleted