NCT06391112

Brief Summary

It is observed that art-based programs, one of the non-pharmacological methods, play an active role in improving the health and well-being of pregnant women and reducing anxiety, stress and depression. This shows that arts-based experiences offer women a unique opportunity to explore all dimensions of the transition to motherhood. When the literature is examined, it is seen that art-based interventions are used in birth units, neonatal intensive care and high-risk pregnancy units. However, no study has been found in which it was applied during the NST procedure. Therefore, the aim of our study is to examine the effect of picture-based art intervention on the fetus during the Non-Stress Test on maternal anxiety and fetal parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

April 25, 2024

Last Update Submit

July 5, 2024

Conditions

Keywords

Art Therapy

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Scale

    The state-trait anxiety scale, developed by Spielberg and his colleagues in 1964 to measure the anxiety levels of normal and abnormal individuals, was adapted into Turkish by Öner and Le Compte (1983). The state anxiety part of the scale, which consists of two parts, will be used. There are 20 statements in both scales and the answer options include four options, each ranging from 1 to 4.

    one week

Secondary Outcomes (1)

  • NST Findings Record Form

    one week

Study Arms (2)

control group

NO INTERVENTION

Pregnant women in the control group will receive standard outpatient clinic treatment.

Experimental group

EXPERIMENTAL

In the research, pregnant women in the Painting-Based Art Intervention group will be asked to imagine their own babies during the NST procedure and after imagining them, they will be asked to draw them in a drawing book.

Other: Painting Based Art intervention

Interventions

Painting Based Art Effect of Intervention on Maternal Anxiety and Fetal Parameters

Experimental group

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Not having any risk factors during pregnancy
  • Lack of uterine contraction
  • No cardiovascular disease diagnosed in the fetus
  • Pregnant women must be between the ages of 18-35

You may not qualify if:

  • Any complications in the pregnancy
  • Any complications in the fetus
  • Refusal to accept the final test to be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Özal Medical Training and Research Hospital

Malatya, 44000, Turkey (Türkiye)

Location

Study Officials

  • Gülçin Nacar

    İnönü University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There is a control and experimental group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

January 1, 2024

Primary Completion

May 20, 2024

Study Completion

June 20, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations