Mother Infant ContactNCT06688604
The Effect of Mother-Infant Contact Barrier on Maternal Sadness and Adaptation
A study testing skin contact in people with Mother Infant Contact, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother Infant Contact
- What is being tested?
- skin contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Sep 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
- Had given birth at Mardin Training and Research Hospital
- No physical and/or mental health issues
- No infectious diseases transmitted through contact
- Agreed to participate in the study
- Able to speak Turkish and/or does not have communication issues
- Single live birth with the baby
- Mothers who gave birth vaginally or via spinal anesthesia and had skin-to-skin contact with their baby within the first 5 minutes postpartum
Who cannot join
- Foreign nationals, immigrants, or those with communication issues
- Individuals with any physical and/or mental health problems
- Those with infectious diseases transmitted through contact
- Individuals who did not agree to participate in the study
- Mothers whose baby was stillborn (ex) after birth
- Mothers whose babies were receiving treatment in the intensive care unit
Show all 9Show fewer
- Those who do not wish to provide a phone number
- Women who gave birth vaginally or via spinal anesthesia and do not wish to establish contact with their baby
- Mothers who gave birth to twins or more babies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Training and research hospital
Mardin, artuklu, 47100
About this study
Official title: The Effect of Infant Attachment Barrier on Maternal Sadness and Adaptation: a Randomized Controlled Trial
This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.
Read the detailed description
This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.
- Conditions
- Mother Infant Contact
- Being tested
- skin contact
- Keywords
- Mother infant contact, contact barrier, maternal sadness, postpartum adaptation, midwifery,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin contactBehavioural
Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth
| Study group | Role | What they receive |
|---|---|---|
| vaginal birth | Experimental | Not described Receives: Behavioral: skin contact |
| Childbirth with spinal and epidural anesthesia | Experimental | Not described Receives: Behavioral: skin contact |
| Cesarean section under general anesthesia | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Sadness and Adaptation
The development, reliability and validity study of the scale was conducted by Küçük and Cesur (Küçük, E. (2022) Postpartum maternity blues assesment scale: Improvement, validity and reliability study) (Thesis No. 727989) [Master's thesis, Sivas Cumhuriyet University] National Thesis Center of the Council of Higher Education.) in 2022. The scale included questions prepared to determine the psychological changes that occur in the mother in the postpartum period and what kind of problems these changes may create in the mother. The scale was created as a 5-point Likert type to be answered by the participants. The scale contains 23 items. The items in the scale were applied as '1- Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5- Strongly Agree'. A high score on the scale indicates that the symptoms of maternal sadness in the postpartum period are high. A scale consisting of three sub-dimensions with 23 items (First Factor 'Maternal self-care dimension', second factor 'Infant care di
Measured: 9 month
Postpartum Self-Assessment Scale
It was decided to be developed by Lederman and Weingarten in 1981 to evaluate the adaptation process of women in the postpartum period to motherhood. It is a 4-point Likert-type scale with 82 items. There are 7 subscales that evaluate the Postpartum Self-Assessment Scale. Each subscale contains 10 to 13 items. 39 of the items in the scale are reverse-biased. The numbers of the reverse-biased items in the scale are as follows; 1, 2, 4, 6, 9, 10, 14, 15,16, 22, 29, 30, 32, 33, 36, 38, 40, 41, 42, 43, 44, 46, 47, 49, 51, 53, 54, 59, 61, 62, 67, 69, 71, 73, 77, 78, 79, 81, 82. The scale is measured with a 4-point assessment. Postpartum adjustment is evaluated based on the results of scores ranging from "1" to "4" (4: "Describes very much," 3: "Partially describes," 2: "Somewhat describes," 1: Does not describe at all"). Scoring for reverse items is done in the opposite way. The lowest possible score for the entire scale is 82, and the highest is 328. Low scores indicate that the adaptatio
Measured: nine mounth
Mother-Infant Contact Barrier Scale
Development of the Scale and Examination of Its Psychometric Properties was conducted by Kömürcü Akik and Durak Batıgün (Akik, B. K., \& Batıgün, A. D. (2020). Mother-Infant Contact Barrier Scale (ABTEÖ): Development and Psychometric Properties. Current Approaches in Psychiatry/Psikiyatride Guncel Yaklasimlar, 12.) in 2020. It was planned to be developed to measure possible contact barriers that may be experienced between the mother and the baby, such as difficulties in adaptation between the mother and the baby after birth and negative experiences related to birth, based on the mother's report. A total of 38-item question pool form was created by the authors. After the preliminary preparations, a 37-item form with Likert-type scores from 1 to 5 ("1 = Doesn't Apply to Me at All", "2 = Doesn't Apply to Me", "3 = Undecided", "4 = Applies to Me Somewhat", and "5 = Applies to Me Completely") was created. The 37-item version of the scale was applied to the participants. As a result of the v
Measured: nine mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Jan 2023
- Primary completion16 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mother Infant ContactStudies 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
- Model description
- Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after cesarean and vaginal birth.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel Bulez, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688604
- Sponsor's protocol ID
- E-2022/14-21
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eyquem A, de Saint Martin J. [Clinical significance of circulating autoantibodies]. Ann Immunol (Paris). 1977 Jan-Mar;128(1-2):285-6. French.
PubMed 322584Bystrova K, Ivanova V, Edhborg M, Matthiesen AS, Ransjo-Arvidson AB, Mukhamedrakhimov R, Uvnas-Moberg K, Widstrom AM. Early contact versus separation: effects on mother-infant interaction one year later. Birth. 2009 Jun;36(2):97-109. doi: 10.1111/j.1523-536X.2009.00307.x.
PubMed 19489802Rowe-Murray HJ, Fisher JR. Operative intervention in delivery is associated with compromised early mother-infant interaction. BJOG. 2001 Oct;108(10):1068-75. doi: 10.1111/j.1471-0528.2001.00242.x.
PubMed 11702839Karimi FZ, Sadeghi R, Maleki-Saghooni N, Khadivzadeh T. The effect of mother-infant skin to skin contact on success and duration of first breastfeeding: A systematic review and meta-analysis. Taiwan J Obstet Gynecol. 2019 Jan;58(1):1-9. doi: 10.1016/j.tjog.2018.11.002.
PubMed 30638460
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infant Attachment Barrier on Maternal Sadness and Adaptation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06688604
- Acronym / sponsor ID
- E-2022/14-21
- Conditions
- Mother Infant Contact
- Keywords
- Mother infant contact, contact barrier, maternal sadness, postpartum adaptation, midwifery,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 14 Nov 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 was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.
Detailed description
This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after cesarean and vaginal birth.
| Arm | Type | Receives |
|---|---|---|
| vaginal birth | Experimental | Behavioral: skin contact |
| Childbirth with spinal and epidural anesthesia | Experimental | Behavioral: skin contact |
| Cesarean section under general anesthesia | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Had given birth at Mardin Training and Research Hospital
- No physical and/or mental health issues
- No infectious diseases transmitted through contact
- Agreed to participate in the study
- Able to speak Turkish and/or does not have communication issues
Key exclusion criteria (9 listed)
- Foreign nationals, immigrants, or those with communication issues
- Individuals with any physical and/or mental health problems
- Those with infectious diseases transmitted through contact
- Individuals who did not agree to participate in the study
- Mothers whose baby was stillborn (ex) after birth
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 |
|---|---|---|
| skin contactEnsuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth | Behavioural | Childbirth with spinal and epidural anesthesia, vaginal birth |
Primary outcome
Maternal Sadness and Adaptation
Time frame: 9 month
The development, reliability and validity study of the scale was conducted by Küçük and Cesur (Küçük, E. (2022) Postpartum maternity blues assesment scale: Improvement, validity and reliability study) (Thesis No. 727989) [Master's thesis, Sivas Cumhuriyet University] National Thesis Center of the Council of Higher Education.) in 2022. The scale included questions prepared to determine the psychological changes that occur in the mother in the postpartum period and what kind of problems these changes may create in the mother. The scale was created as a 5-point Likert type to be answered by the participants. The scale contains 23 items. The items in the scale were applied as '1- Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5- Strongly Agree'. A high score on the scale indicates that the symptoms of maternal sadness in the postpartum period are high. A scale consisting of three sub-dimensions with 23 items (First Factor 'Maternal self-care dimension', second factor 'Infant care di
Postpartum Self-Assessment Scale
Time frame: nine mounth
It was decided to be developed by Lederman and Weingarten in 1981 to evaluate the adaptation process of women in the postpartum period to motherhood. It is a 4-point Likert-type scale with 82 items. There are 7 subscales that evaluate the Postpartum Self-Assessment Scale. Each subscale contains 10 to 13 items. 39 of the items in the scale are reverse-biased. The numbers of the reverse-biased items in the scale are as follows; 1, 2, 4, 6, 9, 10, 14, 15,16, 22, 29, 30, 32, 33, 36, 38, 40, 41, 42, 43, 44, 46, 47, 49, 51, 53, 54, 59, 61, 62, 67, 69, 71, 73, 77, 78, 79, 81, 82. The scale is measured with a 4-point assessment. Postpartum adjustment is evaluated based on the results of scores ranging from "1" to "4" (4: "Describes very much," 3: "Partially describes," 2: "Somewhat describes," 1: Does not describe at all"). Scoring for reverse items is done in the opposite way. The lowest possible score for the entire scale is 82, and the highest is 328. Low scores indicate that the adaptatio
Mother-Infant Contact Barrier Scale
Time frame: nine mounth
Development of the Scale and Examination of Its Psychometric Properties was conducted by Kömürcü Akik and Durak Batıgün (Akik, B. K., \& Batıgün, A. D. (2020). Mother-Infant Contact Barrier Scale (ABTEÖ): Development and Psychometric Properties. Current Approaches in Psychiatry/Psikiyatride Guncel Yaklasimlar, 12.) in 2020. It was planned to be developed to measure possible contact barriers that may be experienced between the mother and the baby, such as difficulties in adaptation between the mother and the baby after birth and negative experiences related to birth, based on the mother's report. A total of 38-item question pool form was created by the authors. After the preliminary preparations, a 37-item form with Likert-type scores from 1 to 5 ("1 = Doesn't Apply to Me at All", "2 = Doesn't Apply to Me", "3 = Undecided", "4 = Applies to Me Somewhat", and "5 = Applies to Me Completely") was created. The 37-item version of the scale was applied to the participants. As a result of the v
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 14 Nov 2024.
- Background: PubMed 322584Eyquem A, de Saint Martin J. [Clinical significance of circulating autoantibodies]. Ann Immunol (Paris). 1977 Jan-Mar;128(1-2):285-6. French.
- Background: PubMed 19489802Bystrova K, Ivanova V, Edhborg M, Matthiesen AS, Ransjo-Arvidson AB, Mukhamedrakhimov R, Uvnas-Moberg K, Widstrom AM. Early contact versus separation: effects on mother-infant interaction one year later. Birth. 2009 Jun;36(2):97-109. doi: 10.1111/j.1523-536X.2009.00307.x.
- Background: PubMed 11702839Rowe-Murray HJ, Fisher JR. Operative intervention in delivery is associated with compromised early mother-infant interaction. BJOG. 2001 Oct;108(10):1068-75. doi: 10.1111/j.1471-0528.2001.00242.x.
- Background: PubMed 30638460Karimi FZ, Sadeghi R, Maleki-Saghooni N, Khadivzadeh T. The effect of mother-infant skin to skin contact on success and duration of first breastfeeding: A systematic review and meta-analysis. Taiwan J Obstet Gynecol. 2019 Jan;58(1):1-9. doi: 10.1016/j.tjog.2018.11.002.
- WHOLink provided by the sponsor.
- 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.
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 skin contact in people with Mother Infant Contact, run by Kahramanmaras Sutcu Imam 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 7 inclusion and 9 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 14 Nov 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 Sadness and Adaptation (time frame: 9 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?
On the ClinicalTrials.gov record for NCT06688604, which also lists 4 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 14 Nov 2024.