Unconscious StateNCT07602998
The Effect of Auditory Stimulation and the "Love Glove" Technique
A study testing Voice of a patient's relative, Voice of nurse and Love glove in people with Unconscious State, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unconscious State
- What is being tested?
- Voice of a patient's relative, Voice of nurse and Love glove
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Auditory Stimulation and the "Love Glove" Technique on Vital Signs in Unconscious Patients
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:
Read more
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.
- Conditions
- Unconscious State
- Being tested
- Voice of a patient's relative, Voice of nurse, Love glove, voice and love glove
- Keywords
- Auditory Stimulation, Love Glove, Vital Signs, Tactile Stimulation
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice of a patient's relativeBehavioural
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.
Voice of nurseBehavioural
The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room
Love gloveBehavioural
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.
voice and love gloveBehavioural
where the patient's voice and the "glove of love" are used together
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Voice of a patient's relative |
| 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 Receives: Behavioral: Voice of nurse |
| Love glove | Experimental | The group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air Receives: Behavioral: Love glove |
| family member's voice+glove of love | Experimental | The patient's family members voice and the "glove of love" will be used together Receives: Behavioral: voice and love glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Blood pressure were recorded on the Form before and after the blood sampling procedure.
Measured: Twice a day for 7 days
pulse
Pulse were recorded on the Form before and after the blood sampling procedure.
Measured: Twice a day for 7 days
oxygen saturation
oxygen saturation were recorded on the Form before and after the blood sampling procedure.
Measured: Twice a day for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unconscious StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602998
- Sponsor's protocol ID
- MCBU-K-CEVIK-006
- Status last verified
- May 2026
- First submitted
- 23 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auditory Stimulation and the "Love Glove" Technique on Vital Signs in Unconscious Patients
- ClinicalTrials.gov ID
- NCT07602998
- Acronym / sponsor ID
- MCBU-K-CEVIK-006
- Conditions
- Unconscious State
- Keywords
- Auditory Stimulation, Love Glove, Vital Signs, Tactile Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| family member's voice | Experimental | Behavioral: Voice of a patient's relativeA 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 | Experimental | Behavioral: Voice of nurseThe 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 | Experimental | Behavioral: Love gloveThe 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 | Experimental | Behavioral: voice and love gloveThe patient's family members voice and the "glove of love" will be used together |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice of a patient's relativeThe 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. | Behavioural | family member's voice |
| Voice of nurseThe audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room | Behavioural | nurse's voice |
| Love gloveLatex 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. | Behavioural | Love glove |
| voice and love glovewhere the patient's voice and the "glove of love" are used together | Behavioural | family member's voice+glove of love |
Primary outcome
blood pressure
Time frame: Twice a day for 7 days
Blood pressure were recorded on the Form before and after the blood sampling procedure.
pulse
Time frame: Twice a day for 7 days
Pulse were recorded on the Form before and after the blood sampling procedure.
oxygen saturation
Time frame: Twice a day for 7 days
oxygen saturation were recorded on the Form before and after the blood sampling procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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CLINICAL INTUITION is an Experience-based, Often Unconscious Assessment of a Patient's Resilience and Tolerance. It is INFLUENCED by Clinical Signs, Behavior, Functioning, and Context. While it MAY PREDICT Patient Dropout, it is Difficult to Objectify.
Clinical Intuition
Recruiting
Unconscious Mind Training
Memory Encoding, Memory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice of a patient's relative, Voice of nurse and Love glove in people with Unconscious State, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: Twice a day for 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.