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

Official title

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

Overview

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.

Interventions

• Behavioral Voice of a patient's relative
  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 se
• Behavioral Voice of nurse
  The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room
• Behavioral Love glove
  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.
• Behavioral voice and love glove
  where the patient's voice and the "glove of love" are used together

Primary outcome measures

• blood pressure [Time frame: Twice a day for 7 days]
• pulse [Time frame: Twice a day for 7 days]
• oxygen saturation [Time frame: Twice a day for 7 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Kivan Çevik Kaya — Manisa

Identifiers

NCT: NCT07602998 · MCBU-K-CEVIK-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗