Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters

August 4, 2022 updated by: Didem Kucukkelepce, Adiyaman University Research Hospital

Effects of Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters: A Randomized Controlled Clinical Trial

The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Çankaya, Ankara, Turkey
        • Lokman Hekim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • - Not having any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy
  • Absence of uterine contraction as a result of NST,
  • No cardiovascular disease diagnosed in the fetus,
  • Being in the 18-49 age group

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
EXPERIMENTAL: maternal touch
Other: tactile stimulation group
The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.
Other Names:
  • maternal touch
Other: listen music
Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.
Other Names:
  • music group
Other: virtual reality group
Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.
EXPERIMENTAL: music group
Other: tactile stimulation group
The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.
Other Names:
  • maternal touch
Other: listen music
Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.
Other Names:
  • music group
Other: virtual reality group
Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.
EXPERIMENTAL: virtual reality group
Other: tactile stimulation group
The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.
Other Names:
  • maternal touch
Other: listen music
Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.
Other Names:
  • music group
Other: virtual reality group
Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal heart rate, fetal movement
Time Frame: 20 minutes
number
20 minutes
Maternal anxiety
Time Frame: 20 minutes
STAI State Anxiety Inventory The emotions and behaviors expressed in the State Anxiety Inventory (STAI TX-I) items are answered by marking one of the options such as (1) never, (2) a little, (3) a lot, (4) completely, according to the severity of such experiences. The options in the Anxiety Scale are "almost never"(1), "sometimes"(2), "often"(3), "almost always"(4). Scoring ranges from 1 to 4. In the scale, there are direct or straight and reversed statements. Direct statements indicate negative emotions, reversed statements indicate positive emotions.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adiyaman University Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2022

Primary Completion (ACTUAL)

July 7, 2022

Study Completion (ACTUAL)

July 10, 2022

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (ACTUAL)

August 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lokman hekim university (Other Identifier: Lokman hekim university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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