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

16 maj 2026 uppdaterad av: Celal Bayar University

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:

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • MANİSAYunusemre
      • Manisa, MANİSAYunusemre, Turkiet (Türkiye)
        • Kivan Çevik Kaya

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollera
Inget ingripande
Experimentell: family member's voice
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.
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.
Experimentell: nurse's voice
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
The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room
Experimentell: Love glove
The group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air
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.
Experimentell: family member's voice+glove of love
The patient's family members voice and the "glove of love" will be used together
where the patient's voice and the "glove of love" are used together

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
blood pressure
Tidsram: Twice a day for 7 days
Blood pressure were recorded on the Form before and after the blood sampling procedure.
Twice a day for 7 days
pulse
Tidsram: Twice a day for 7 days
Pulse were recorded on the Form before and after the blood sampling procedure.
Twice a day for 7 days
oxygen saturation
Tidsram: Twice a day for 7 days
oxygen saturation were recorded on the Form before and after the blood sampling procedure.
Twice a day for 7 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 juni 2026

Avslutad studie (Beräknad)

1 april 2028

Studieregistreringsdatum

Först inskickad

23 mars 2026

Först inskickad som uppfyllde QC-kriterierna

16 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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