An interventional study of Voice of a patient's relative and Voice of nurse in Unconscious State, sponsored by Manisa Celal Bayar University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Manisa Celal Bayar University · Not applicable, Interventional, and Supportive care
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.
60 studies on the registry are indexed under Unconsciousness; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 37 interventional studies indexed under Unconsciousness.
Browse Unconsciousness studies →Manisa Celal Bayar University is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
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.
Behavioral: Voice of a patient's relative
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
Behavioral: Voice of nurse
The group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air
Behavioral: Love glove
The patient's family members voice and the "glove of love" will be used together
Behavioral: voice and love glove
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.
The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room
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.
where the patient's voice and the "glove of love" are used together
blood pressure
Blood pressure were recorded on the Form before and after the blood sampling procedure.
Time frame: Twice a day for 7 days
pulse
Pulse were recorded on the Form before and after the blood sampling procedure.
Time frame: Twice a day for 7 days
oxygen saturation
oxygen saturation were recorded on the Form before and after the blood sampling procedure.
Time frame: Twice a day for 7 days
Plan to share: No
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Manisa Celal Bayar University