Health TrialsbyHealthPanel

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

ConditionUnconscious State
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelal Bayar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: family member's voiceExperimental treatment 1 intervention
Group C: nurse's voiceExperimental treatment 1 intervention
Group D: Love gloveExperimental treatment 1 intervention
Group E: family member's voice+glove of loveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

blood pressure

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

Time frame
Twice a day for 7 days
2

pulse

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

Time frame
Twice a day for 7 days
3

oxygen saturation

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

Time frame
Twice a day for 7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celal Bayar University

Lead sponsor

Source ClinicalTrials.gov

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