Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07602998

The Effect of Auditory Stimulation and the "Love Glove" Technique

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Unconscious State Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kivan Çevik Kaya

Manisa, MANİSAYunusemre, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

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.

voice and love glove

Behavioral

where the patient's voice and the "glove of love" are used together

Primary outcomes

  1. blood pressure

    Time frame: Twice a day for 7 days

    Blood pressure were recorded on the Form before and after the blood sampling procedure.

  2. pulse

    Time frame: Twice a day for 7 days

    Pulse were recorded on the Form before and after the blood sampling procedure.

  3. oxygen saturation

    Time frame: Twice a day for 7 days

    oxygen saturation were recorded on the Form before and after the blood sampling procedure.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

The Effect of Auditory Stimulation and the "Love Glove" Technique on Vital Signs in Unconscious Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.