- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07929337
The Effect of Virtual Reality Headset and Hand Massage on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Who Have Undergone Abdominal Surgery
The Effect of Virtual Reality Headset and Hand Massage on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Who Have Undergone Abdominal Surgery: A Single-Blind, Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of using a virtual reality headset and conventional hand massage on pain, anxiety, patient satisfaction, and physiological parameters in patients undergoing abdominal surgery. Participants will be randomly assigned to three groups: the virtual reality group, the conventional hand massage group, and the control group. Pain levels, anxiety levels, satisfaction levels, and physiological parameters will be assessed both before and after the procedure. The study aims to determine whether these non-pharmacological methods improve postoperative pain, anxiety, patient satisfaction, and physiological parameters.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Principal Investigator
- Numero di telefono: +90 232 412 4779
- Email: gizemgoktuna@gmail.com
Luoghi di studio
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Izmir, Turchia (Türkiye)
- Dokuz Eylul University
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Contatto:
- Principal Investigator
- Numero di telefono: +90 232 412 4779
- Email: gizemgoktuna@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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• Aged 18 and older
- Who have not previously undergone abdominal surgery
- Who underwent elective surgery
- Who had a numerical pain scale score of 3 or higher prior to the procedure
- Possessing the cognitive ability to tolerate the virtual reality headset application
- Voluntarily agreeing to participate in the study
- Patients on the second postoperative day
- No history of chronic pain (e.g., arthritis)
- Patients who are alert and oriented enough to communicate (Glasgow Coma Scale 15)
- Patients with normal vision and hearing
- Patients suitable for hand massage
- Patients who are not addicted to alcohol or drugs
- Patients not taking anxiolytics
- Patients who can read and understand Turkish
Exclusion Criteria:
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• Those under the age of 18
- Those with vision or hearing loss
- Those who are not clinically stable
- Those who have undergone emergency surgery
- Those with a known history of epilepsy, vertigo, or limited mobility
- Those with surgical incisions or wounds in the facial area that prevent them from wearing VR goggles
- Those using chronic opioids or psychiatric medications
- Individuals with open wounds, burns, infections, phlebitis, ecchymosis, hematomas, or fractures on their hands
- Patients with an intravenous catheter in their hand
- Those who wish to withdraw from the study during the research period
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Virtual Reality Group
Immediately before the procedure, the fourth researcher will administer the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form to patients on the second postoperative day at the clinic. Next, the second researcher will fit the patient with a virtual reality headset, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 15 minutes. After 15 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the fourth researcher will have the patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. |
Immediately before the procedure, the fourth researcher will administer the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form to patients on the second postoperative day at the clinic. Next, the second researcher will fit the patient with a virtual reality headset, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 15 minutes. After 15 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the fourth researcher will have the patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. This distraction technique aims to reduce pain perception and anxiety levels, increase patient satisfaction during the procedure, and improve physiological parameters.
Altri nomi:
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Sperimentale: Classic Hand Massage Group
Immediately before the intervention, the fourth researcher will administer the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form to patients on the second postoperative day at the clinic. Next, the second researcher will perform a classic hand massage for a total of 15 minutes-7.5 minutes on the right hand followed by 7.5 minutes on the left hand. After 15 minutes, the classical hand massage will be discontinued. Immediately after the intervention and 30 minutes later, the fourth researcher will have the patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. |
Immediately before the intervention, the fourth researcher will administer the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form to patients on the second postoperative day at the clinic. Next, the second researcher will perform a classic hand massage for a total of 15 minutes-7.5 minutes on the right hand followed by 7.5 minutes on the left hand. After 15 minutes, the classical hand massage will be discontinued. Immediately after the intervention and 30 minutes later, the fourth researcher will have the patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. This distraction technique aims to reduce pain perception and anxiety levels, increase patient satisfaction during the procedure, and improve physiological parameters.
Altri nomi:
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Nessun intervento: Control Group
During the initial patient encounter, the fourth researcher will administer the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form. In routine clinical practice, care will be continued by the nurse responsible for the patient's care. The second researcher will not perform any additional interventions. At the same time as the group receiving the virtual reality headset application and conventional hand massage, the fourth researcher will have the patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative pain
Lasso di tempo: The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
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Pain intensity will be measured using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (the most severe pain possible). Measurements will be taken three times: on the second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later. |
The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative anxiety levels
Lasso di tempo: The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Anxiety levels will be assessed using the Situational Anxiety Inventory - Short Form (STAIS-S). This scale measures temporary anxiety levels. Scores range from 20 to 80. Measurements will be taken three times: on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate higher (worse) anxiety levels. |
The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Post-surgery satisfaction levels
Lasso di tempo: The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Patient satisfaction will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not at all satisfied) to 10 (extremely satisfied). Measurements will be taken three times: on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate greater satisfaction. |
The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Systolic Blood Pressure
Lasso di tempo: The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher systolic blood pressure. |
The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Diastolic Blood Pressure
Lasso di tempo: The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher diastolic blood pressure. |
The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Pulse Rate
Lasso di tempo: The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Pulse rate will be measured in beats per minute (beats/min). |
The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Respiratory Rate
Lasso di tempo: The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Respiratory rate will be measured in breaths per minute (breaths/min). |
The second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Collaboratori e investigatori
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Altri numeri di identificazione dello studio
- 2026/37-04
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