About this trial
The aim of this study is to determine the effects of virtual reality glasses (VRG) and meditation music on anxiety, pain, vital signs, satisfaction and pregnancy outcomes during the embryo transfer (ET) procedure.
H1: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on anxiety.
H2: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on pain.
H3: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on vital signs (pulse rate, blood pressure, respiration).
H4: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on patient satisfaction.
H5: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on pregnancy outcomes.
35 women will be included in the VRG+meditation group, 35 women in the meditation group, and 35 women in the control group. The first group will be shown a nature view with VRG and will listen to meditation music 15 minutes before the ET. The second group will be shown meditation music 15 minutes before the embryo transfer. No intervention will be made in the third group. In the first two groups, anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration, and peripheral oxygen saturation) will be assessed 15 minutes before and immediately after the ET procedure. In the first group, satisfaction with the ET procedure, VRG application, and listening to meditation music will be assessed 15 minutes after the ET procedure. In the second group, satisfaction with the ET procedure and listening to meditation music will be assessed 15 minutes after the ET procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being diagnosed with primary infertility
Having had an embryo transfer for the first time
Disqualifiers
Using antidepressants or sedatives
Using painkillers within 24 hours before the procedure
Having hearing and vision impairment
Removing glasses during the procedure
Trial design
Parallel
Treatments tested in this trial
VR glasses and meditation music group
BehavioralStarting 15 minutes before the ET procedure, participants in the VR glasses and meditation music group will be shown a video of the sea, underwater and forest with VR glasses and will be made to listen to meditation music. At the same time, meditation music will be played. When the ET procedure is completed, the video and meditation music will be stopped. After the procedure, the VR glasses will be disinfected with antiseptic spray before being used on another patient, and disposable ear pads will be placed on the headphones after each patient. Anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration and peripheral oxygen saturation) will be evaluated 15 minutes before and immediately after the ET procedure. 15 minutes after the ET procedure, satisfaction with the ET procedure, the application of VR glasses and listening to meditation music will be evaluated.
Meditation music group
BehavioralMeditation music group participants will listen to meditation music through headphones starting from 15 minutes before the ET procedure until the procedure is completed. When the ET procedure is completed, the meditation music will be stopped. After the procedure, disposable ear pads will be placed on the headphones for each patient. Anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration and peripheral oxygen saturation) will be assessed 15 minutes before and immediately after the ET procedure. 15 minutes after the ET procedure, satisfaction with the ET procedure and listening to meditation music will be assessed.
Treatment groups
Trial outcomes
Primary outcomes
State-Trait Anxiety Scale
Anxiety will be assessed using the State-Trait Anxiety Scale. The original name of the scale is State-Anxiety Invertory. The scale was developed by Spielberger \[1970\] and adapted to Turkish by Oner and Le Compte (1983). It consists of 20 items rated on a four-point Likert-type scale. The scale describes how people feel under different conditions and at that moment. The inventory is in the form of a four-point Likert scale. The total score varies between 20 and 80, and higher scores indicate higher anxiety levels. The Cronbach's alpha value of the scale is 0.94 \[1983\].
VAS-Pain
Pain will be assessed using the Visual Analog Scale (VAS). The VAS is a 10 cm long horizontal line. The women marks the point on the line that they think represents their perception of their current condition. The VAS score is determined by measuring in millimeters from the left end of the line to the point marked by the women. The left most end of the line includes the expressions "no pain (0 points)" and the right most end includes the expressions "unbearable pain (10 points)" (Wewers and Lowe 1990).
Change from Baseline Pulse Rates
Women's pulses will be measured and recorded 15 minutes before the ET procedure and immediately after the ET procedure is completed.
Change from Baseline Blood Pressure
Women's blood pressure will be measured and recorded 15 minutes before the ET procedure and immediately after the ET procedure is completed.
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