Attachment DisorderNCT05723887
Attachment-Based, Attachment, Prenatal
A study testing Attachment-Based Intervention Program in people with Attachment Disorder, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The sample of the study consisted of a total of 154 pregnant women (77 experiments, 77 controls). An attachment-based intervention program (ABIP) was applied to pregnant women in the experimental group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attachment Disorder
- What is being tested?
- Attachment-Based Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Feb 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over the age of 18, and maimum age 40
- Pregnancy week between 24-40 weeks
Who cannot join
- Pregnant women with psychological diagnosis according to records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Attachment-Based Intervention Program on Attachment, Prenatal
This randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The sample of the study consisted of a total of 154 pregnant women (77 experiments, 77 controls). An attachment-based intervention program (ABIP) was applied to pregnant women in the experimental group. The ABIP included five interventions; (1) Perceiving/counting fetal movements, (2) Music therapy, (3) Preparation for the baby, (4) Writing notes/letters to the baby, and (5) Watching images of the fetus/pregnancy.
Read the detailed description
This study aimed to determine the effect of attachment-based intervention program on attachment, prenatal expectation and stress level in pregnant women. This randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The sample of the study consisted of a total of 154 pregnant women (77 experiments, 77 controls). An attachment-based intervention program (ABIP) was applied to pregnant women in the experimental group. The ABIP included five interventions; (1) Perceiving/counting fetal movements, (2) Music therapy, (3) Preparation for the baby, (4) Writing notes/letters to the baby, and (5) Watching images of the fetus/pregnancy. The program was completed in a total of 5 days, one session per day.
- Conditions
- Attachment Disorder
- Being tested
- Attachment-Based Intervention Program
- Keywords
- prenatal distress, pregnancy, Midw,ifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment-Based Intervention ProgramBehavioural
Attachment-Based Intervention Program
| Study group | Role | What they receive |
|---|---|---|
| Experimental (ABIP group) | Experimental | The ABIP was created by the researchers in line with the literature and consisted of interventions that affect and increase prenatal attachment Gölbaşı et al., 2015; Güney \& including perceiving /counting fetal movements, music therapy, preparation for the baby, writing notes/letters to the baby, watching images of the fetus/pregnancy. The program was completed in a total of five days, with one intervention per day. An ABIP kit, which contained the materials to be used by pregnant women during ABIP interventions, was provided to them by the researchers at the first meeting. ABIP intervention materials were included in the ABIP kit, using five different colored envelopes (Appendix 1). Pregnant women were also informed about the interventions and materials of ABIP by the researchers at the first meeting. Receives: Behavioral: Attachment-Based Intervention Program |
| control groups | No intervention | No Intervention: Control group standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Antenatal Attachment
It has a total of 19 items, focusing on pregnant women's feelings, attitudes and behaviors towards the fetus. This is a 5-point Likert type scale, scoring between 1 (the absence of feelings toward the fetus) and 5 (strong emotions toward the fetus).
Measured: one week
Secondary outcomes (1)
Prenatal Maternal Expectations
This is a 5-point Likert type scale, scoring from 1 (strongly agree) to 5 (strongly disagree). It consists of 34 items and two subscales: (1) Unrealistic Positive Prenatal Expectations (21 items measuring the mother's positive expectations about childbirth and motherhood role), (2) Unrealistic Negative Prenatal Expectations (13 items measuring the mother's negative expectations about childbirth and motherhood role).
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Aug 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attachment DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Tuba Uçar
- Responsible party
- Principal investigator, Esra SABANCI BARANSEL, Inonu University
- Investigators
- Esra sabancı Baransel, asst. prof., Principal investigator, esraa.sabancii@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723887
- Sponsor's protocol ID
- 2020/605
- Status last verified
- Mar 2024
- First submitted
- 13 Jan 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data were not shared
Publications
Golbasi Z, Ucar T, Tugut N. Validity and reliability of the Turkish version of the Maternal Antenatal Attachment Scale. Jpn J Nurs Sci. 2015 Apr;12(2):154-61. doi: 10.1111/jjns.12052. Epub 2014 Jun 24.
PubMed 24962076Pisoni C, Garofoli F, Tzialla C, Orcesi S, Spinillo A, Politi P, Balottin U, Tinelli C, Stronati M. Complexity of parental prenatal attachment during pregnancy at risk for preterm delivery. J Matern Fetal Neonatal Med. 2016 Mar;29(5):771-6. doi: 10.3109/14767058.2015.1017813. Epub 2015 Mar 9.
PubMed 25747945Yuksel F, Akin S, Durna Z. Prenatal distress in Turkish pregnant women and factors associated with maternal prenatal distress. J Clin Nurs. 2014 Jan;23(1-2):54-64. doi: 10.1111/j.1365-2702.2012.04283.x. Epub 2013 Jan 11.
PubMed 23305376
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Attachment-Based Intervention Program on Attachment, Prenatal
- ClinicalTrials.gov ID
- NCT05723887
- Acronym / sponsor ID
- 2020/605
- Conditions
- Attachment Disorder
- Keywords
- prenatal distress, pregnancy, Midw,ifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Tuba Uçar
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 13 Feb 2023 (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 randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The sample of the study consisted of a total of 154 pregnant women (77 experiments, 77 controls). An attachment-based intervention program (ABIP) was applied to pregnant women in the experimental group. The ABIP included five interventions; (1) Perceiving/counting fetal movements, (2) Music therapy, (3) Preparation for the baby, (4) Writing notes/letters to the baby, and (5) Watching images of the fetus/pregnancy.
Detailed description
This study aimed to determine the effect of attachment-based intervention program on attachment, prenatal expectation and stress level in pregnant women. This randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The sample of the study consisted of a total of 154 pregnant women (77 experiments, 77 controls). An attachment-based intervention program (ABIP) was applied to pregnant women in the experimental group. The ABIP included five interventions; (1) Perceiving/counting fetal movements, (2) Music therapy, (3) Preparation for the baby, (4) Writing notes/letters to the baby, and (5) Watching images of the fetus/pregnancy. The program was completed in a total of 5 days, one session per day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (ABIP group) | Experimental | Behavioral: Attachment-Based Intervention ProgramThe ABIP was created by the researchers in line with the literature and consisted of interventions that affect and increase prenatal attachment Gölbaşı et al., 2015; Güney \& including perceiving /counting fetal movements, music therapy, preparation for the baby, writing notes/letters to the baby, watching images of the fetus/pregnancy. The program was completed in a total of five days, with one intervention per day. An ABIP kit, which contained the materials to be used by pregnant women during ABIP interventions, was provided to them by the researchers at the first meeting. ABIP intervention materials were included in the ABIP kit, using five different colored envelopes (Appendix 1). Pregnant women were also informed about the interventions and materials of ABIP by the researchers at the first meeting. |
| control groups | No intervention | –No Intervention: Control group standard care group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Over the age of 18, and maimum age 40
- Pregnancy week between 24-40 weeks
Key exclusion criteria (1 listed)
- Pregnant women with psychological diagnosis according to records
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 |
|---|---|---|
| Attachment-Based Intervention ProgramAttachment-Based Intervention Program | Behavioural | Experimental (ABIP group) |
Primary outcome
Maternal Antenatal Attachment
Time frame: one week
It has a total of 19 items, focusing on pregnant women's feelings, attitudes and behaviors towards the fetus. This is a 5-point Likert type scale, scoring between 1 (the absence of feelings toward the fetus) and 5 (strong emotions toward the fetus).
1 secondary outcome
Prenatal Maternal Expectations
Time frame: one week
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 7 Mar 2024.
- Results publication: PubMed 24962076Golbasi Z, Ucar T, Tugut N. Validity and reliability of the Turkish version of the Maternal Antenatal Attachment Scale. Jpn J Nurs Sci. 2015 Apr;12(2):154-61. doi: 10.1111/jjns.12052. Epub 2014 Jun 24.
- Results publication: PubMed 25747945Pisoni C, Garofoli F, Tzialla C, Orcesi S, Spinillo A, Politi P, Balottin U, Tinelli C, Stronati M. Complexity of parental prenatal attachment during pregnancy at risk for preterm delivery. J Matern Fetal Neonatal Med. 2016 Mar;29(5):771-6. doi: 10.3109/14767058.2015.1017813. Epub 2015 Mar 9.
- Results publication: PubMed 23305376Yuksel F, Akin S, Durna Z. Prenatal distress in Turkish pregnant women and factors associated with maternal prenatal distress. J Clin Nurs. 2014 Jan;23(1-2):54-64. doi: 10.1111/j.1365-2702.2012.04283.x. Epub 2013 Jan 11.
- Individual participant dataSharing planned: No. individual participant data were not shared
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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.
Esra sabancı Baransel, asst. prof. principal investigator
esraa.sabancii@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment-Based Intervention Program in people with Attachment Disorder, run by Inonu 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 2 inclusion and 1 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 7 Mar 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?
Maternal Antenatal Attachment (time frame: one week). 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 NCT05723887, which also lists 3 linked publications.
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 7 Mar 2024.