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| ID | Type | Description | Link |
|---|---|---|---|
| 24-18-Nov-2025 | Other Identifier | University of Baghdad , College of Nursing Research Ethics Committee |
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This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery. Many patients experience sleep disturbances and discomfort due to the sound of the mechanical valve. Participants will be randomly assigned to one of two non-drug interventions to see which method improves sleep and reduces discomfort after surgery. The study aims to help improve recovery and comfort for patients after valve replacement.
This randomized clinical trial will evaluate the effects of four interventions on sleep disturbances and patient discomfort in adult patients after prosthetic mechanical valve replacement. Sleep disturbances are common due to the sound of the mechanical valve. Participants will be randomly assigned to one of four groups: (1) VR Group (2) Binaural Beat Group listening to binaural beats for 20 minutes (3) VR + Binaural Beat Group combining both interventions, and (4) Control Group receiving standard postoperative care without interventions. Primary outcomes include sleep quality and patient-reported discomfort measured during the early postoperative period. The study aims to identify which intervention or combination is most effective in improving recovery and patient comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Group | Experimental | Guided VR relaxation sessions |
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| Binaural Beat Group | Experimental | sessions BBS for reducing discomfort and enhance sleep quality |
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| VR + Binaural Beat Group | Experimental | Combined VR & BBS sessions |
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| Control Group | Other | Standard postoperative care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Relaxation | Behavioral | Guided VR relaxation sessions to reduce discomfort an enhance sleep quality |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Discomfort | Patient-reported discomfort measured using the Kolcaba Verbal Rating Comfort Scale (KCS), assessing the intensity of postoperative discomfort following prosthetic mechanical valve replacement. This measure captures the level of discomfort experienced by the patient during hospitalization that result from mechanical valve sound. | From postoperative day 3 until discharge from the cardiac surgery ward |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waffa AR Hattab, Ph.D. | University of Baghdad, College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ibn Al-Nafees Teaching Hospital | Baghdad | Baghdad Governorate | Iraq |
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| Label | URL |
|---|---|
| University of Baghdad, College of Nursing | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study not yet published / Data | Study not yet published / Data not available | View IPD |
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Randomization ensures that each participant has an equal chance of being assigned to any group, and all groups are followed concurrently to compare outcome.
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Not applicable - study is open label; all participants and staff are aware of the interventions.
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| Binaural Beat Stimulation | Behavioral | Guide sessions BBS to reduce discomfort and enhance sleep quality |
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| VR + Binaural Beat Group | Behavioral | Combined VR & BBS sessions |
|
| Standard Postoperative care | Other | Usual postoperative care for patients |
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Study not yet published |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D006349 | Heart Valve Diseases |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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