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

16. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Ingen indgriben
Eksperimentel: 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.
Adfærdsmæssigt: 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 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.
Eksperimentel: 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
Adfærdsmæssigt: 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
Eksperimentel: Love glove
The group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air
Adfærdsmæssigt: 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.
Eksperimentel: family member's voice+glove of love
The patient's family members voice and the "glove of love" will be used together
Adfærdsmæssigt: voice and love glove
where the patient's voice and the "glove of love" are used together

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
blood pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Celal Bayar University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

23. marts 2026

Først indsendt, der opfyldte QC-kriterier

16. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MCBU-K-CEVIK-006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ubevidst tilstand

Kliniske forsøg med Voice of a patient's relative

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner