NCT05017909

Brief Summary

The research consists of two stages. First Stage: It is the development of the scale for gaining the role of motherhood in primiparas according to the scale development stages. In order to define the subject and determine the scope, the content analysis will be determined by interviewing the sample group that will not be included in the pilot application and the final scale application and the primipara people with similar characteristics. As a result, the item pool will form the basis together with the literature. An item pool related to gaining the role of motherhood will be created, the opinions of experts will be taken to evaluate the scope and appearance validity of the scale, and adjustments will be made in the item pool according to expert opinions. In order to determine the validity and reliability of the scale, half of the participants will be tested-retested. The internal consistency reliability of the scale will be determined by the Cronbach Alpha reliability coefficient. In addition, Edinburgh Postpartum Depression Scale (EDDS) and Mother-Infant Attachment Scale (MIAS), which are similar scales, will be used in the scale development phase for the validity of the scale. Second stage: The training consisting of 3 modules is planned. MODULE: Mother Module MODULE: Infant Module MODULE: Breastfeeding Module At this stage of the study, pregnant women who meet the sampling criteria will be divided into groups. The determination of the groups will be according to the Randomized numbers table. Pregnant women who will enter the web-based training group (Experimental group 1), Face-to-face training group (Experimental group 2) and the control group will be determined. The personal information form containing the socio-demographic data and the final scale developed to gain the role of motherhood in primiparas will be applied to the participants who volunteered to participate in the study. Experimental Initiative: A web-based and face-to-face training program will be planned and implemented as separate groups for the sampled participants. Post-Test Application of the Final Scale: The final scale, which was developed to gain the role of motherhood in primiparas, will be administered to the participants in the sample group as a post-test on the 40th day. By analyzing the data obtained, the effectiveness of the scale and the difference between the pre-test scores of the participant group after the training program will be examined.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

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

May 24, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

May 24, 2021

Last Update Submit

August 21, 2021

Conditions

Keywords

Primipara PregnancyRole of MotherhoodWeb-Based Education

Outcome Measures

Primary Outcomes (1)

  • The effect of education on the role of motherhood

    As a result of our research, a motherhood role acquisition scale will be developed. This developed scale will be applied to pregnant women in the last trimester. By providing web-based or face-to-face training, it will be determined which training method has a positive or negative effect on gaining the role of motherhood.

    1 year and 6 months

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

3-week web-based education group

Behavioral: Web based education

Experimental Group 2

EXPERIMENTAL

3-week face to face education group

Behavioral: Face to face education

Control Group

ACTIVE COMPARATOR

Uneducated group

Behavioral: No education

Interventions

Face to face education techniques on the acquisition of the mothering Role

Experimental Group 2

web based education techniques on the acquisition of the mothering Role

Experimental Group 1
No educationBEHAVIORAL

Control group will not be educated

Control Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having a primiparous pregnancy,
  • In the last trimester of pregnancy,
  • At least primary school graduate,
  • Able to read and understand Turkish,
  • Use the internet actively and regularly access the website and receive training,
  • Do not have any physical, mental or social problems that may prevent participation in face-to-face or web-based education and pregnant women who accepted the study will be included in the study.

You may not qualify if:

  • Pregnant women who cannot access the website,
  • Have any congenital defect in their baby,
  • Experience mother-baby separation,
  • Want to leave the research before the end of the research will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Feride Yiğit

    Hasan KU

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Student

Study Record Dates

First Submitted

May 24, 2021

First Posted

August 24, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

September 1, 2022

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share