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The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery

31 de octubre de 2026 actualizado por: Gizem Göktuna, Dokuz Eylul University

The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery: A Randomized Controlled Trial

This randomized controlled trial aims to investigate the effects of virtual reality headset use on pain, anxiety, patient satisfaction, and physiological parameters in patients undergoing open-heart surgery. Participants will be randomly assigned to two groups: the virtual reality 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 this non-pharmacological method improves postoperative pain, anxiety, patient satisfaction, and physiological parameters.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

44

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Aged 18 and older
  • Who have not previously undergone open-heart surgery
  • Non-emergency, elective surgeries
  • Who have not taken pain medication 4-6 hours prior to the procedure
  • Who have a numerical pain scale score of 3 or higher prior to the procedure
  • Patients with sufficient cognitive ability to tolerate the virtual reality headset application
  • Patients who voluntarily agree to participate in the study
  • Patients extubated on the second postoperative day
  • Patients with no history of chronic pain (e.g., arthritis)
  • Being alert and oriented enough to communicate (Glasgow Coma Scale 15)
  • Not being addicted to alcohol or drugs
  • Not using anxiolytics
  • Having no psychological problems (such as depression or anxiety disorders)
  • Being able to read and understand Turkish

Exclusion Criteria:

  • • Under 18 years of age

    • With vision or hearing loss
    • Clinically unstable
    • With a known history of epilepsy, vertigo, or limited mobility
    • With a surgical incision or scar on the face that prevents wearing VR goggles
    • Chronic opioid use or use of psychiatric medications

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Virtual Reality Group

For patients admitted to the ward for surgery, the researcher will have them complete the State Anxiety Scale and the Satisfaction Scale one day before surgery. On the third postoperative day in the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form.

One day before surgery, the researcher will have participants in this group complete the State Anxiety Scale and the Satisfaction Scale. On the third postoperative day at the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the 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.

Otros nombres:
  • Gafas de Realidad Virtual
Sin intervención: Control Group

Patients admitted to the ward for surgery will complete the State Anxiety Scale and the Satisfaction Scale administered by the researcher one day before surgery. Patients will be admitted to the clinic on the third postoperative day, and their care will continue to be provided by the nurse responsible for their care as part of routine clinical practice. The researcher will not perform any additional interventions. At the same time as the group receiving the virtual reality headset intervention, the researcher will again have patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form.

(Measurements will be taken during the preoperative period; however, patients who do not meet the inclusion criteria postoperatively will not be included in the study.)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
postoperative pain
Periodo de tiempo: The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.

Pain intensity will be measured using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain) immediately after the procedure. 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Preoperative and postoperative anxiety levels
Periodo de tiempo: One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

Anxiety levels will be assessed using the State Anxiety Inventory-Short Form (STAIS-S). The scale measures temporary anxiety levels. Scores range from 20 to 80. Measurements will be taken four times: one day before surgery; 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.

One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Pre- and post-surgery satisfaction levels
Periodo de tiempo: One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

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 four times: one day before surgery; 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.

One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Systolic Blood Pressure
Periodo de tiempo: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher systolic blood pressure.

On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Diastolic Blood Pressure
Periodo de tiempo: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher diastolic blood pressure.

On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Pulse Rate
Periodo de tiempo: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

Pulse rate will be measured in beats per minute (beats/min).

On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Respiratory Rate
Periodo de tiempo: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

Respiratory rate will be measured in breaths per minute (breaths/min).

On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de septiembre de 2026

Publicado por primera vez (Actual)

28 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de octubre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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