The Effect of Music on Nonstress Test and Pregnant Women's Satisfaction

NCT06137872 | Unknown

• 1 other identifier: KoceliU
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted as a randomized controlled trial. This study was conducted to determine the effect of music on nonstress test and pregnant woman's satisfaction. The study was conducted with pregnant women who applied for non-stress testing at a hospital in Samsun, Turkey, between September 2021 and September 2022. Pregnant women who met the research criteria were divided into two groups: physical and control groups. The research was completed experimentally with a total of 111 pregnant women, 56 experimental and 55 control. The researcher had a face-to-face interview with all the pregnant women and filled out the "Pregnant Introduction Form". Then, the vital signs of the pregnant women were taken and the pregnant women were placed in the left side-lying position. Fundus height, situs and position were determined using Leopold maneuvers. During the non-stress test shooting, the music group was allowed to listen to music for at least 20 minutes during the NST period. No intervention was made to the control group. After the non-stress test is completed, the "Satisfaction Evaluation Scale" is taken by the pregnant woman herself. The "Nonstress Test Monitoring Form" was filled out by the researcher through notification. The data of the study were evaluated using the Statistical Package for the Social Sciences program. All data were first analyzed by Kolmogorov-Smirnov for conformity with normal distribution. were evaluated and then analyzed according to their suitability for normal distribution. For descriptive statistics, percentage across the board, arithmetic mean±standard deviation for those with normal distribution, median and minimum-maximum values for those that did not fit were used. In the analysis of the data, student t test and ANOVA test were used for those that were suitable for normal distribution, and Mann-Whitney U and Kruskal Wallis tests were used for those that were not suitable for normal distribution. Type 1 error level was taken as 0.05.

Conditions

Music

Keywords

music; non-stress test; pregnant

Outcome Measures

Primary Outcomes (9)

• Fetal heart rate

  After the non-stress test was taken, the basal fetal heart rate on the non-stress test paper was calculated.

  Immediately after non-stress test

• Variability

  After the non-stress test was taken, the variability rate on the non-stress test paper was calculated. 1. Increased variability (change greater than 25 beats/min from basal heart rate) 2. Moderate variability (6-25 beats/min change from basal heart rate) 3. Decreased variability (3-5 beats/min change from basal heart rate) 4. No variability (0-2 beats/min change from basal heart rate)

  Immediately after non-stress test

• Presence of fetal movement

  After the non-stress test was taken, the presence of fetal movement on the non-stress test paper was calculated.After the non-stress test, the presence of fetal movement will be evaluated as presence/absence on the evaluation sheet, and if there is fetal movement, the number is determined.

  Immediately after non-stress test

• Presence of acceleration

  After taking the non-stress test, the presence of acceleration was calculated on the non-stress test paper. After the non-stress test, the presence of acceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.

  Immediately after non-stress test

• Time to first acceleration

  As a result of the non-stress test, the time until the first acceleration was calculated.

  Immediately after non-stress test

• Presence of deceleration

  After taking the non-stress test, the presence of deceleration was calculated on the non-stress test paper. After the non-stress test, the presence of deceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.

  Immediately after non-stress test

• The type of deceleration

  According to the non-stress test results, 1. Early deceleration 2. Late deceleration 3. Variable deceleration evaluation was performed.

  Immediately after non-stress test

• Nonstress test result

  Evaluations are made according to the nonstress test results 1. Reactive (negative) non-stress test (here should be at least two fetal movements within a 20-minute period, and in parallel with the movements, the fetal heart Accelerations in which the heart rate is more than 15 beats above the basal heart rate and last more than 15 seconds It will be said to be) 2. Nonreactive (positive) non-stress test (Absence of fetal movements or presence of fetal movements within 20 minutes It will be defined as the presence of accelerations that are less than a beat and last less than 15 seconds) 3. Questionable non-stress test evaluation was performed.

  Immediately after non-stress test

• Satisfaction Evaluation Scale

  This scale was adapted by researchers similar to the "Visual Analog Scale " usage principles. Visual Analog Scale is a scale evaluated by individuals by making marks on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad". This line can be just a straight line or evenly spaced.

  Immediately after non-stress test

Study Arms (2)

Music Group

EXPERIMENTAL

During the non-stress test shooting, the music group was allowed to listen to music via headphones once for at least 20 minutes.

Other: Music Group

Control Group

EXPERIMENTAL

No application was made and non-stress test shooting was performed.

Other: Control Group

Interventions

Music Group OTHER

Pregnant women who came to the hospital for non-stress testing were met and informed about the study. The procedure was applied for non-stress testing. In the music group, the pregnant woman, who was assigned to the next group according to randomization during the non-stress test, was allowed to listen to music with disposable headphones for at least 20 minutes until the procedure was completed. At the same time, the mother will be asked to close her eyes and be relaxed. Headphones used to prevent infection were given to the pregnant woman as a gift at the end of the procedure.

Music Group

Control Group OTHER

Pregnant women who came to the hospital for non-stress testing were met and informed about the study. The procedure was applied for non-stress testing. During the non-stress test, routine non-stress test was performed on the pregnant control group, which was assigned to the next group according to randomization.

Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Preganant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are between the ages of 18-35,
• Pregnancy week 32 and above,
• Having a singleton and live pregnancy,
• Have had non-stress test at least once before,
• Able to speak and understand Turkish,
• Pregnant women who were at least primary school graduates were included in the study.
• Conditions to be met before Nonstress Testing
• Eating at least two hours before the non-stress test,
• Do not smoke, drink alcohol or use drugs for at least two hours before the non-stress test,
• Do not engage in vigorous activity for at least two hours before the non-stress test,
• Nonstress urinates just before the test,
• Basal heart rate is 110-160 beats per minute

You may not qualify if:

• Criteria for Excluding Preganat in the Research
• Having uterine contraction as a result of nonstress test,
• In any situation that develops acutely during the non-stress test,
• Those who cannot complete non-stress test for any reason,
• Psychologically diagnosed (such as depression, schizophrenia)
• Having any chronic disease (such as diabetes, hypertension, heart failure)
• Having pregnancy complications (such as preeclampsia, gestational diabetes, Rh incompatibility)
• Having a history of infertility and becoming pregnant with assisted reproductive techniques,
• Having a problem identified in the fetus (anomaly, intrauterine growth retardation and cardiovascular disease),
• Pregnant women who provided incorrect or incomplete information were not included in the study.

Sponsors & Collaborators

• Resmiye KAYA ODABAŞ: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yasemin Sökmen, Dr

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

• Resmiye Kaya Odabaş, Dr

  Kocaeli University

  STUDY CHAIR

• Bahadır Yazıcıoğlu, Dr

  Samsun Provincial Health Directorate

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: September 2, 2021
• Primary Completion: September 12, 2022
• Study Completion: December 1, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)