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The aim of this study was to determine the effect of the "love glove" intervention, combined with the voices of family members and nurses, on vital signs in unconscious patients in the intensive care unit. The following items will be used to collect research data: Patient Information Form (Appendix I), Data Recording Form (Appendix II), MP3 player, external headphones and voice recorder, latex gloves, and thermometer.
Data Collection Tools:
Patient Identification Form : A form containing patients' sociodemographic characteristics and their Glasgow Coma Scale score prior to the start of the study Data Recording Form: A form used to record patients' level of consciousness and hemodynamic parameters before and after the auditory stimulation procedure.
Methods This study is a randomized controlled trial designed to determine the effect of applying a family member's voice, a nurse's voice, and the "love glove" on vital signs in unconscious patients admitted to the intensive care unit. Following approval from the ethics committee, the study is planned to be conducted with comatose patients admitted to the hospital's intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention | |
| family member's voice | Experimental | A pre-recorded message will be played and recorded for the patient's family members, featuring a prepared script that includes the patient's name, the family member's name, and their relationship to the patient, as well as information on the patient's location and phrases conveying hope and love. |
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| nurse's voice | Experimental | The audio recording made by the researcher will also be played for the other intervention group, to whom the nurse's voice will be played |
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| Love glove | Experimental | The group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air |
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| family member's voice+glove of love | Experimental | The patient's family members voice and the "glove of love" will be used together |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice of a patient's relative | Behavioral | The audio recording of the patient's family member will be made in a quiet and calm room. Care will be taken to select family members who have a strong emotional bond with the patient for the recording. When determining which family member will be recorded, the patient's first-degree relatives will be consulted, and the family's collective decision will be taken into account; in addition to the family member being recorded, consent will be obtained from another family member who volunteers to serve as a witness for this person via a consent form. A preliminary interview will be conducted with the family member selected for the audio recording in a suitable room, and they will be asked to recite the standard script. Family members will be given as much time as they need to prepare for the audio recording. |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | Blood pressure were recorded on the Form before and after the blood sampling procedure. | Twice a day for 7 days |
| pulse | Pulse were recorded on the Form before and after the blood sampling procedure. | Twice a day for 7 days |
| oxygen saturation | oxygen saturation were recorded on the Form before and after the blood sampling procedure. | Twice a day for 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kivan Çevik Kaya | Manisa | MANİSAYunusemre | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014831 | Voice |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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Patients will be assigned to 5 groups using a computer-assisted block randomization method. The study will be divided into 5 groups: the group receiving the patient's voice, the group receiving the nurse's voice, the group receiving the love glove, the combined group receiving both the patient's voice and the love glove, and the control group.
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Although blinding of the investigators could not be achieved due to the nature of the interventions, the person assessing vital signs and the person conducting the statistical analysis will be blinded to the groups.
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| Voice of nurse | Behavioral | The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room |
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| Love glove | Behavioral | Latex medical gloves will be filled with warm water (37°C) and air to prevent pressure ulcers and provide a sensation of human touch. The gloves will be connected to each other and placed on both of the patient's hands, and the treatment will be applied for 15 minutes. |
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| voice and love glove | Behavioral | where the patient's voice and the "glove of love" are used together |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |