The Effect of Virtual Reality and Music in High-Risk Pregnants on Non-Stress Test

NCT05495789 | Completed

• 1 other identifier: 12/125
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The aim of this study is to determine the effects of virtual reality and listening to music during the NST procedure on NST parameters, anxiety and satisfaction in high-risk pregnant. Hypotheses H01 In the NST process, there is no difference between the NST parameters of the virtual reality group and the NST parameters of the control group. H02 In the NST procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group. H03 There is no difference between the satisfaction score of the group in which virtual reality was applied in the NST procedure and the satisfaction score of the control group. H04 In the NST process, there is no difference between the NST parameters of the group to which the virtual reality is applied and the NST parameters of the musical group. H05 In the NST procedure, there was no difference between the anxiety score of the group in which virtual reality was applied and the anxiety score of the music group. H06 In the NST process, there is no difference between the satisfaction score of the group to which the virtual reality was applied and the satisfaction score of the music group. H07 In NST operation, there is no difference between the NST parameters of the music group and the NST parameters of the control group. H08 In the NST procedure, there was no difference between the anxiety score of the music group and the anxiety score of the control group. H09 There is no difference between the satisfaction score of the music group and the satisfaction score of the control group in the NST procedure.

Conditions

High Risk Pregnancy

Outcome Measures

Primary Outcomes (8)

• Change in anxiety

  STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

  immediately before the NST procedure and immediately after the NST procedure

• the degree of satisfaction

  VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.

  immediately after the NST procedure

• Non-Stress Test Parameters/ basal fetal heart rate

  It is the average fetal heart rate sustained over a 10-minute period and 120-160 beats/minute is normal.

  immediately after the NST procedure

• Non-Stress Test Parameters: number of accelerations

  Acceleration an increase in fetal heart rate.

  immediately after the NST procedure

• Non-Stress Test Parameters/ number of decelerations

  Deceleration is the slowing of fetal heart rate seen on the monitor during contractions.

  immediately after the NST procedure

• Non-Stress Test Parameters/ reactive nst

  Reactive NST; It is a normal result showing that accelerations occur at least twice within a maximum of 20 minutes, are at least 15 beats/min more than the basal level and continue for 15 seconds.

  immediately after the NST procedure

• Non-Stress Test Parameters / Test time (minutes) for reactive NST

  Time until reactive NST result is obtained.

  immediately after the NST procedure

• Non-Stress Test Parameters / Non-reaktif NST

  Non-reactive NST; An abnormal result showing that less than two of the accelerations that are at least 15 beats/min above baseline occur in a 40 min time frame.

  immediately after the NST procedure

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

In addition to the routine procedure, virtual reality glasses will be applied to the high-risk pregnant in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After the NST device is connected and, the high-risk pregnant included in the experimental group will be made to watch a video lasting an average of 40 minutes with virtual reality glasses until the procedure is completed.

Other: Virtual Reality

Music Group

EXPERIMENTAL

In addition to the routine procedure, the high-risk pregnant women in the music group of the research will listen to the relaxing music used in the virtual reality application with headphones.

Other: Music

Control Group

NO INTERVENTION

The high-risk pregnants in the control group of the study will not be subjected to any treatment other than the routine procedure.

Interventions

Virtual Reality OTHER

A relaxing video will be watched with virtual reality glasses.

Virtual Reality Group

Music OTHER

Relaxing music will be played by wearing headphones.

Music Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at the 32nd and above gestational week
• Pregnant women with a single fetus
• Have eaten at least two hours before the NST procedure
• No cardiovascular disease diagnosed in the fetus,
• The participants ate at least 2 h before the NST, urinated immediately before the NST and did not smoke or drink alcohol for at least 2 h before the NST.
• Those diagnosed with high-risk pregnancy by a physician (pregnancy-induced hypertension, preeclampsia, eclampsia, gestational diabetes, premature rupture of membranes, pregnancy large or small for gestational age, intrauterine growth retardation, polihydramnios, oligohydramnios, premature birth threat, maternal age 35 age and above, maternal body mass index over 30 (obesity)
• Not having vision and hearing problems

You may not qualify if:

• Pregnant women with major medical (cardiac, renal or neurological diseases) or mental illnesses (psychosis, neurosis, addictions, etc.)
• healty pregnant women
• multiple pregnancy
• having a fetus with anomaly,
• Pregnant women with fetal distress and for whom emergency intervention is considered by the physician

Sponsors & Collaborators

• NESLİHAN YILMAZ SEZER: lead

Study Sites (1)

Neslihan Yılmaz Sezer

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• AYKAN YÜCEL, Prof.Dr.

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty of Nursing

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: January 9, 2023
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)