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CompletedNCT06688604Updated Nov 14, 2024

The Effect of Mother-Infant Contact Barrier on Maternal Sadness and Adaptation

An interventional study of skin contact in Mother Infant Contact, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jan 2023, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
351
Allocation
Randomized
Sex
Female
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Study 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. 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.

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Conditions studied

  • Mother Infant Contact

Keywords

  • Mother infant contact, contact barrier, maternal sadness, postpartum adaptation, midwifery,
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In context

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
351 participants (actual)

Study arms

  • Experimental
    vaginal birth

    Behavioral: skin contact

  • Experimental
    Childbirth with spinal and epidural anesthesia

    Behavioral: skin contact

  • No intervention
    Cesarean section under general anesthesia

Interventions

  • Behavioralskin contact

    Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 month

  2. 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

    Time frame: nine mounth

  3. 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

    Time frame: nine mounth

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Study locations

1 site
  • Mardin Training and research hospital
    Mardin, Artuklu 47100, Turkey
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References and documents

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 322584 ↗
  • Bystrova 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 19489802 ↗
  • Rowe-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 11702839 ↗
  • Karimi 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 ↗

Related links

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06688604
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Aysel Bulez (Principal Investigator, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Nov 14, 2024
Start date
Jan 1, 2023
Primary completion
Aug 16, 2023
Completion
Sep 1, 2023
Last update
Nov 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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