Unconscious State
Conditions
Keywords
Auditory Stimulation, Love Glove, Vital Signs, Tactile Stimulation
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.
Interventions
BEHAVIORALVoice 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 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.
BEHAVIORALVoice of nurse
The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room
BEHAVIORALLove 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.
BEHAVIORALvoice and love glove
where the patient's voice and the "glove of love" are used together
Sponsors
Celal Bayar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | Twice a day for 7 days | Blood pressure were recorded on the Form before and after the blood sampling procedure. |
| pulse | Twice a day for 7 days | Pulse were recorded on the Form before and after the blood sampling procedure. |
| oxygen saturation | Twice a day for 7 days | oxygen saturation were recorded on the Form before and after the blood sampling procedure. |
Countries
Turkey (Türkiye)
Outcome results
None listed