The Effect of Auditory Stimulation and the "Love Glove" Technique
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
Study Completion
Last participant's last visit for all outcomes
April 1, 2028
May 22, 2026
May 1, 2026
Same day
March 23, 2026
May 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (5)
Control
NO INTERVENTIONNo intervention
family member's voice
EXPERIMENTALA 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.
nurse's voice
EXPERIMENTALThe audio recording made by the researcher will also be played for the other intervention group, to whom the nurse's voice will be played
Love glove
EXPERIMENTALThe group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air
family member's voice+glove of love
EXPERIMENTALThe patient's family members voice and the "glove of love" will be used together
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients in a coma who have been hospitalized in the intensive care unit for at least 48 hours, have a Glasgow Coma Scale score of 8 or lower,
- have no hearing problems,
- are hemodynamically stable,
- are either on mechanical ventilation or breathing spontaneously, have no history of head trauma,
- have received informed consent from their legal representative
You may not qualify if:
- Patients with open wounds,
- those diagnosed with brain death,
- those whose sedative or analgesic doses were adjusted during the study,
- those with severe hemodynamic instability,
- patients with latex allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kivan Çevik Kaya
Manisa, MANİSAYunusemre, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
April 1, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share