Effects of Virtual Reality Glasses and Meditation Music on Anxiety, Pain, Vital Signs, Satisfaction and Pregnancy Outcomes in Embryo Transfer Procedure

Condition(s) studied

Investigational drug(s) / intervention(s)

VR glasses and meditation music group: Starting 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: Meditation 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.

Study summary

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

Primary outcome measure(s)

• State-Trait Anxiety Scale — To be administered to women 15 minutes before the ET procedure and immediately after the ET procedure is completed (the ET procedure is 20 minutes). Change in baseline State-Trait Anxiety Scale scores at the end of 35 minutes.
  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 — Applied to women immediately before the ET procedure and immediately after the ET procedure is completed (ET procedure is 20 minutes). Change in baseline VAS-Pain scores after 20 minutes.
  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 — Pulse will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from baseline pulse rates after 35 minutes.
  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 — Blood pressure will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from baseline blood pressure after 35 minutes.
  Women's blood pressure will be measured and recorded 15 minutes before the ET procedure and immediately after the ET procedure is completed.
• Change from Baseline Respiratory Rates — Respiratory rates will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from respiratory rates after 35 minutes.
  Women's respiratory rates will be measured and recorded 15 minutes before the ET procedure and immediately after the ET procedure is completed.
• Change from Baseline Oxygen Saturation (SpO2) — Oxygen saturation will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from oxygen saturation after 35 minutes.
  Women's oxygen saturation will be measured and recorded 15 minutes before the ET procedure and immediately after the ET procedure is completed.
• VRG+meditation music group satisfaction form — This form must be filled out on the same day, 15 minutes after the ET process is completed.
  This form was prepared to determine satisfaction with the ET procedure, the video watched with the virtual reality glasses, and the meditation music listened to. The first question of the 1st intervention group asks whether they are satisfied with the virtual reality glasses application. The second question asks whether they are satisfied with the meditation music. The third question asks whether they are satisfied with the ET procedure. In these questions, women will be asked to indicate their satisfaction levels on a 10-centimeter horizontal line. The line starts with 0 (Not satisfied at all) and ends with 10 (Very satisfied). The fourth question asks whether they would like to use the virtual reality glasses if the procedure is repeated, and the fifth question asks whether they would like to listen to meditation music if the procedure is repeated. The fourth and fifth questions are answered as yes, no, and undecided.
• Meditation music group satisfaction form — This form must be filled out on the same day, 15 minutes after the ET process is completed.
  This form was prepared to determine satisfaction with the ET procedure and the meditation music listened to.The first question of the 2nd intervention group asks whether they are satisfied with the meditation music. The second question asks whether they are satisfied with the ET procedure. In these questions, women will be asked to indicate their satisfaction levels on a 10-centimeter horizontal line. The line has a value of 0 (I am not satisfied at all) at the beginning and 10 (I am very satisfied) at the end. The third question asks whether they would like to listen to meditation music if the procedure is repeated. This question is answered with yes, no and undecided.
• Control group ET process satisfaction form — This form must be filled out on the same day, 15 minutes after the ET process is completed.
  The control group is only asked whether they are satisfied with the ET procedure. In this question, women are asked to indicate their satisfaction levels on a 10-centimeter horizontal line. The line has a value of 0 (I am not satisfied at all) at the beginning and 10 (I am very satisfied) at the end.

Trial sites (1)

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