Özlem Çiçek
Izmir, 35360, Turkey (Türkiye)
NCT Number: NCT05955716
The aim of this clinical study is to compare the pain and fear scores of women who gave birth for the first time and who did and did not do relaxation exercises with virtual reality glasses during episiotomy incision and episiotomy repair.
This research seeks answers to the following questions:
Question 1: Does doing relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy incision? Question 2: Does relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy repair? Question 3: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy incision? Question 4: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy repair? A group of participants will be given a relaxation exercise with virtual reality glasses during the episiotomy incision and episiotomy repair. Women in the comparison group will not undergo any intervention during episiotomy incision and repair.
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Notify Me18 year and older
Female
Interventional
Not applicable
Izmir, 35360, Turkey (Türkiye)
This research is a single-blind, randomized controlled experimental study with pre-post and control groups. The population of the study consisted of pregnant women who applied to the Delivery Room in İzmir Bakırçay University Çiğli Training and Research Hospital Travay Birth Postpartum Service. The data pool could not be created because the sample was composed of women who applied for childbirth. In this randomized controlled trial, block randomization was applied. Because when simple randomization is applied, there may be a large difference between the numbers of subjects in the two groups when the study is completed. As the difference between the number of pregnant women in the virtual reality glasses and control groups grows, the reliability of the statistical analysis will decrease. Simple randomization is not recommended in cases where the sample size is less than 200. Although it was planned to take 38 experimental and 38 control group samples that met the inclusion criteria, the block randomization was carried out on 100 people, taking into account the exclusion criteria from the sample.
The randomization of the sample was made using the "random number generation program (Research Randomizer)". Intervention and control groups were formed by performing the randomization process by an impartial researcher who was not involved in the research. While it was known by the researchers in which group the pregnant women were, unilateral blindness was provided by not informing the pregnant women about the groups they were in. Since it is recommended in the literature that each step of randomized controlled trials should be performed according to the Consolidated Standards of Reporting Trials (CONSORT), this study was also conducted according to CONSORT. The type 1 error level of the study was determined as 5% (p=o.o5), the type II error level was 0.20 (80% power) and the effect size was 0.3 (moderate). Data were collected between December 2022 and May 2023. Data collection takes an average of 15 minutes.
Virtual Reality Glasses Group:
Pregnant women in the virtual reality glasses group who agreed to participate in the study and watch a relaxation video with virtual reality glasses were expected to answer the questions in the socio-demographic and obstetric information form during the latent phase of labor. Afterwards, they were asked about how many points of pain and fear they would experience on the VAS during the episiotomy incision and repair, on a scale of 0-10. After this form was answered, a relaxation video was watched with virtual reality glasses during the episiotomy incision and repair. After these procedures, as soon as the episiotomy incision and episiotomy repair were completed, virtual reality glasses were removed and the score of pain and fear they experienced was asked. They were asked to rate the pain and fear they experienced, giving a score between 0-10.
Control Group:
Pregnant women who agreed to participate in the study and who would be in the control group were expected to answer the questions in the socio-demographic and obstetric information form during the latent phase of labor. Afterwards, they were asked to score an estimated 0-10 score for pain and fear levels with VAS during episiotomy incision and repair. After this form was answered, no intervention was made during the episiotomy incision and repair, except routine practice. After these procedures, as soon as the episiotomy incision and episiotomy repair were completed, they were asked about the score of pain and fear they experienced. They were asked to rate the pain and fear they experienced, giving a score between 0-10.
Hypotheses:
H1- Relaxation exercise performed with virtual reality glasses reduces the perineal pain score experienced while performing the episiotomy incision.
H1- Relaxation exercise with virtual reality glasses reduces the perineal pain score experienced during episiotomy suturing.
H1- Relaxation exercise performed with virtual reality glasses reduces the fear score experienced while applying the episiotomy incision.
H1- Relaxation exercise with virtual reality glasses reduces the fear score experienced during episiotomy suturing.
Data collection tool(s):
Statistical method(s) to be used:
Data analysis will be done with SPSS 26 package program. In the evaluation of data; mean, standard deviation and percentage values will be calculated. In order to evaluate the homogeneity of the data according to the groups, the Skewness-Curtosis values will be examined and the tests to be used in the analysis will be decided. A probability value of p<0.05 will be considered statistically significant.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the study:
Exclusion criteria
from the study:
Virtual reality glasses are a device suitable for every mobile phone. It is used to watch the 360 degree video selected from the Youtube program.
Time frame: Immediately after episiotomy incision
She evaluated the pain experienced during the episiotomy incision with the help of a visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the scores indicates an increase in the level of pain.
Time frame: Immediately after episiotomy repair
She evaluated the pain experienced during the episiotomy repair with the help of visual analog scale. A minimum score of 0 and a maximum score of 10 are taken from this scale, and an increase in scores indicates an increase in the level of pain.
Time frame: Immediately after episiotomy incision
She evaluated the fear experienced during the episiotomy incision with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in score indicates an increase in the level of fear.
Time frame: Immediately after episiotomy repair
She evaluated the fear experienced during the episiotomy repair with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in score indicates an increase in the level of fear.
Time frame: Latent phase of birth
She was asked to estimate how many points of pain he would have experienced during the episiotomy incision. She was asked to answer this question with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the score indicates that she predicts that the pain she will experience will also be high.
Time frame: Latent phase of birth
She was asked to estimate how many points of pain he would have experienced during the episiotomy repair. She was asked to answer this question with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the score indicates that she predicts that the pain she will experience will also be high.
Time frame: Latent phase of birth
She was asked to estimate how many points of fear she would have experienced during the episiotomy incision. She was asked to answer this question with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the score indicates that she predicts that the fear she will experience will also be high.
Time frame: Latent phase of birth
She was asked to estimate how many points of fear she would have experienced during the episiotomy repair. She was asked to answer this question with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the score indicates that she predicts that the fear she will experience will also be high.
Özlem Çiçek
Other
The Effect of Relaxation Exercise Applied With Virtual Reality Glasses on Episiotomy-induced Perineal Pain Score and Fear: A Single-Blind Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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