The Effect of Virtual Reality on Women Undergoing Endometrial Biopsy
ConditionEndometrial Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorOndokuz Mayıs University
About this trial
The aim was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety.
Hypotheses H0: Virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy.
H1: Virtual reality glasses have an effect on women's pain and anxiety during endometrial biopsy.
The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an endometrial biopsy. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sounds music of the video will be played in the practice room with a bluetooth speaker.
Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
*Being over 18 years old
Speaking and understanding Turkish
Being willing to participate in the research
Disqualifiers
Not volunteering to participate in research * Not speaking or understanding Turkish
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Group
Other interventioncontrol group
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Numerical Pain Scale
It was developed to measure the pain level of patients. It is named differently at two ends on a vertical or horizontal line of ten centimeters (cm) in length (0=no pain, 10=highest level of pain). The numerical values specified by the patient indicate the pain intensity. The validity and reliability of the scale have been performed. It has been determined that it is a suitable method for assessing the pain intensity.
Time frame
immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure2
Change in anxiety
STAI-S It is a self-assessment type scale consisting of short statements. While the State Anxiety Inventory (SAI) provides information only about what is felt at that moment, the Trait Anxiety Inventory (TAI) was developed to measure what has been felt in the last 7 days. The SAI-SAI is a Likert-type scale consisting of 20 items and graded from 1 to 4. It is reported that the reliability coefficients obtained as a result of studies conducted with normal and patient samples of the scale vary between .83 and .87
Time frame
immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedureSponsors and contacts
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Source ClinicalTrials.gov