NCT06723184

Brief Summary

Although there are studies in the literature on the effects of antenatal education on pregnant women, there are no interventional studies on the education of grandmothers, who play an important role in the care of the newborn baby. Therefore, the aim of this study is to examine the effects of antenatal education given to grandmothers on anxiety and self-confidence in baby care. The type of study is a randomized controlled experimental study with pre-post and control groups. The training will be given face to face to grandmothers reached through social media. At the beginning of the study, the sample size was calculated in the G-Power program by taking as reference a similar study in which the same scale (Pharis Self-Confidence Scale) was used. According to the t-test in independent groups, 95% confidence interval, 95% power and high effect size (0.98), a total of 48 people were required, 24 experimental and 24 control. Women who apply to receive training will be assigned to intervention and control groups in a block randomised manner according to their application numbers. Intention-to-treat analysis will be performed to prevent bias and losses. A total of six hours of training will be provided to the intervention group. The program content will be prepared by researchers based on literature and using childbirth preparation education philosophies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 14, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

October 14, 2024

Last Update Submit

December 11, 2025

Conditions

Keywords

Grandmother educationGrandchild careSense of self-confidence

Outcome Measures

Primary Outcomes (4)

  • Introductory Information Form

    This form, created in line with the literature, consists of 9 questions that include some socio-demographic characteristics of grandmothers.

    It will be applied to both the experimental and control groups within 3 days before the training.

  • Knowledge Measurement Survey for Grandchild Care

    This survey will be used to measure the knowledge level of grandmothers on topics parallel to the training content to be created and the effectiveness of the planned training. The survey consists of 25 questions.

    It will be applied to both the experimental and control groups within 3 days before the training.

  • State and Trait Anxiety Scale

    The scale was developed by Spielberger et al to determine state and trait anxiety levels separately . The Turkish adaptation of the form was made by Öner et al. The Cronbach Alpha value of the State Anxiety Scale was found to be between 0.83-0.87, and the Cronbach Alpha value of the Trait Anxiety Scale was found to be between 0.94-0.96. The inventory has two separate scales, each consisting of 20 items: 1. State Anxiety Scale: Determines how the individual feels at a certain moment and under certain conditions. 2. Trait Anxiety Scale: Determines how the individual generally feels, regardless of the situation and conditions they are in.

    It will be applied to both the experimental and control groups within 3 days before the training.

  • Pharis Self-Confidence Scale

    First developed by Pharis and later by Walker the internal consistency reliability was found to be between 71-91 in a study. In 2003, the validity reliability in Turkey was made by Hüsniye Çalışır. The Pharis self-confidence scale, a 13-item five-point measurement tool, measures a parent's own feelings of confidence about daily baby care. Each baby care item is rated from one (not at all) to five (completely). A high score indicates high self-confidence in baby care. The Cronbach alpha internal consistency coefficient of the scale was found to be 0.86

    It will be applied to both the experimental and control groups within 3 days before the training.

Secondary Outcomes (3)

  • Knowledge Measurement Survey for Grandchild Care

    The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.

  • State and Trait Anxiety Scale

    The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.

  • Pharis Self-Confidence Scale

    The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.

Study Arms (2)

Experimental grup

EXPERIMENTAL

Experimental grup

Behavioral: The training

Control group

NO INTERVENTION

No intervention grup

Interventions

The trainingBEHAVIORAL

Behavioral: Antenatal Education Education Hours: The training will be completed in a total of three weeks and six hours, two hours each week. Method: The training will be in a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Grandmothers in both the control and intervention groups will be asked to fill out the "Introductory Information Form, Pharis Self-Confidence Scale, State-Trait Anxiety Scale and Knowledge Measurement Questionnaire for Grandchild Care" measurement tools. The data of the intervention group will be filled in before and after the training. The data of the control group will be filled in parallel with the intervention group. At the end of the study, the same training will be applied to the control group. Group to receive training: Grandmothers who are expecting a grandchild and have a grandchild will be included in the training.

Experimental grup

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWilling to have grandchildren or having grandchildren
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily accepting to participate in the study
  • At least primary school graduate
  • Willing to have grandchildren or having grandchildren
  • Not diagnosed with any psychiatric illness

You may not qualify if:

  • Not willing to participate in the study
  • Not having at least a primary school degree
  • Being diagnosed with a psychiatric disorder
  • Not having grandchildren or not having grandchildren

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University Faculty of Health Sciences

Denizli, Kınıklı, 20160, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single blind pre-post test randomized controlled design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate student

Study Record Dates

First Submitted

October 14, 2024

First Posted

December 9, 2024

Study Start

December 13, 2024

Primary Completion

February 10, 2025

Study Completion

October 10, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations