NCT06537973

Brief Summary

Purpose of the research: This study aimed to examine the effects of individualized care and counseling given to mothers in the first trimester after birth on maternal attachment, maternal self-efficacy and maternal function. In this context, the hypotheses of the research are as follows:

  1. 1.Individualized care and counseling does not have a significant effect on the level of maternal attachment.
  2. 2.Individualized care and counseling does not have a positive effect on mothers\' self-efficacy perceptions.
  3. 3.Individualized care and counseling does not have a significant effect on the gain of maternal function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

5 days

First QC Date

July 29, 2024

Last Update Submit

July 31, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Mother-to-Infant Bonding Scale (ABBÖ)

    It is a scale that allows the mother to express the feelings she feels towards her baby with a single word. It is a 4-point Likert type scale consisting of 8 items. Responses consisting of four options are scored between 0-3. The lowest score that can be obtained from the scale is 0, while the highest score is 24.

    It will be applied in the 4th and 12th weeks.

  • Maternal Attachment Scale (MBS)

    It is a one-dimensional scale consisting of a total of 26 items in a four-point Likert type that measures maternal feelings and behaviors that show love. The expressions were determined as "always (a) (4 points)", "often (b) (3 points)", "sometimes (c) (2 points)" and "never (d) (1 point)". The lowest score to be obtained from the scale is 26 and the highest score is 104. A high score indicates high maternal attachment.

    It will be applied in the 6th and 12th weeks.

  • Parental Self-Efficacy Scale (EÖSÖ)

    It is an 18-item, 5-point Likert type scale developed to determine parents' personal judgments about their competence in the parental role. The answers to the items on the scale are listed as "Totally Agree", "Agree", "Undecided", "Disagree" and "Strongly Disagree".

    It will be applied in the 6th and 12th weeks.

  • Barkin Maternal Function Scale (BAFÖ)

    The seven-point Likert type scale, developed to evaluate the functional status of the mother after birth, consists of a total of 16 questions. Responses on the scale are expressed as 0 "strongly disagree", 1 "disagree", 2 "somewhat disagree", 3 "undecided", 4 "somewhat agree", 5 "agree", 6 "completely agree". The lowest score that can be obtained from the scale is 0 and the highest score is 96. Evaluation is made based on the total score. A high score means that the maternal function is high.

    It will be applied in the 6th and 12th weeks.

Secondary Outcomes (3)

  • Maternal Attachment Scale (MBS)

    It will be applied in the postpartum weeks.

  • Parental Self-Efficacy Scale (EÖSÖ)

    It will be applied in the 12th week.

  • Barkin Maternal Function Scale (BAFÖ)

    It will be applied in the 6th week.

Study Arms (2)

Experimental group

EXPERIMENTAL

In the first 48 hours after birth; A single-session training including postpartum care, breastfeeding and baby care will be given to mothers in the hospital room where they are hospitalized, practices will be taught and mothers will be encouraged to perform the practices. 2nd week; Counseling will be provided to mothers who have previously been trained by contacting them via phone call. 4th week; Phone calls will be planned with mothers, ABBÖ will be implemented, and the counseling and support provided will continue. 6th week; A telephone interview will be planned with the mothers, MBÖ, EÖÖÖ and BAFÖ will be applied, an evaluation will be made and consultancy will be provided on the issues they need. 8th week; A phone call will be planned with the mothers, an evaluation will be made, care plans will be maintained and counseling will be provided. 12th week; Mothers will be contacted via phone and the MBÖ, EÖYÖ and BAFÖ scales will be applied as a posttest.

Other: İndividualized care education

Control Group

NO INTERVENTION

The researchers will not provide any training or counseling to the mothers other than the standard care and services offered in the hospital. In order to ensure equality, a prepared training booklet will be given to mothers in the control group.

Interventions

A single session of training will be given to the mothers in the experimental group. In addition, the mother will be provided with counseling by the researcher at any time she wishes. The aim is to increase the mother-infant bonding levels and self-efficacy of the mothers, who will be supported by the care plans that will be created based on Swanson\'s Theory of Care, and to adapt more easily to the role of motherhood, by evaluating them with the help of check-lists after the observations.

Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being primiparous
  • Having a vaginal birth
  • Having given birth at term
  • Being 18 years or older
  • Having a single, healthy baby
  • Must be at least a primary school graduate
  • The mother does not have a diagnosed chronic or psychiatric disease.
  • Volunteering to participate in the study

You may not qualify if:

  • Having a history of risky pregnancy
  • Participated in any birth preparation training program
  • The mother shows signs of mental or physical illness (self-report/clinical diagnosis).
  • Inability to communicate effectively with the mother
  • The baby has a health problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Study Officials

  • Emel EGE Prof. Dr.

    Necmettin Erbakan University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Since the researcher must provide training and manage the process, researcher and participant blinding cannot be done. Blinding in data entry; Randomization will be done by an independent researcher outside the scope of the research and the list created will be hidden from the researcher and the participants. Participants will not be informed about which group they are in until the intervention begins.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel group (experiment-control) randomized controlled experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 5, 2024

Study Start

July 31, 2024

Primary Completion

August 5, 2024

Study Completion

September 15, 2024

Last Updated

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

After the study is completed, the parts to be shared will be discussed again and a decision will be made.

Locations