- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07593430
The Effect of Aromatherapy Massage-Based Sensory Stımulatıon Program on Cognıtıve and Sensory Functıon ın Intensıve Care Patıents
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: nilgün erdoğan
- Telefonnummer: +905312599220
- E-post: nilgunerdogan37@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with acute brain injury,
- Glasgow Coma Score (GCS) between 6 and 12,
- Intubated or monitored on oxygen,
- 18 years of age or older,
- Between 24 and 48 hours after hemodynamic vital signs stabilized and without a history of delirium,
- Patients without a history of diseases that increase the risk of odor sensitivity, such as epilepsy or asthma,
Exclusion Criteria:
- Glasgow Coma Score (GCS) below 6,
- Hemodynamic instability,
- Continuously using neuromuscular blocking agents during the study,
- Changes in treatment schedule during the study,
- History of diseases that increase the risk of odor sensitivity, such as epilepsy or asthma,
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: group that applied
aromatherapy
|
Sensory stimulation program performed by a family member of the patient using aromatherapy massage.
|
|
Placebo komparator: intervention 2
lavender
|
Sensory stimulation program performed by a nurse using aromatherapy massage.
|
|
Placebo komparator: plasebo group
control
|
routine nursing practice
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Aromatherapy massage, applied twice daily, and sensory stimulation programs administered by family members have an effect on cognitive sensory perception levels (Glasgow Coma Score (GCS)
Tidsramme: 1 year
|
The GCS score ranges from 3 to 15. Eye opening (1-4), motor activity (1-6), and verbal response (1-5) are all indicators. The lowest possible GCS score is 3 for deep coma or death, while the highest is 15 for a fully awake person. In the study, for the control and monitoring of the intervention groups, a 30-minute massage with aromatic oil will be applied to the patient's chest and back half an hour before the start of visiting hours, in accordance with the application protocol. Then, a visit will be made between 11:00 and 11:30, and a sensory stimulation program will be conducted. Patient Identification Form and Patient Monitoring Form will be completed by the interviewer fellows. Similarly, half an hour before visiting hours in the evening, a 30-minute massage with aromatic oil will be applied to the patient's chest and back by the principal investigator. |
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Aromatherapy massage applied twice daily and sensory stimulation programs administered by family members are effective on cognitive sensory perception levels, Rancho Los Amigos (RLA) Cognitive Function Scale).
Tidsramme: 1 year
|
Aromatherapy massage applied twice daily and sensory stimulation programs administered by family members are effective on cognitive sensory perception levels, Rancho Los Amigos (RLA) Cognitive Function Scale). The Rancho Los Amigos (RLA) Cognitive Function Scale is used to assess behavioral and cognitive patterns of brain damage. The scale indicates the progression of cognitive recovery as demonstrated through behavioral changes. Scores for responses range from 1 to 8; "1" indicates no response (complete help) and "8" purposeful and appropriate response (independent) shown as a cognitive function. In the study, for the control and monitoring of the intervention groups, a 30-minute massage with aromatic oil will be applied to the patient's chest and back half an hour before the start of visiting hours, in accordance with the application protocol. Then, a visit will be made between 11:00 and 11:30, and a sensory stimulation program will be conducted. |
1 year
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The SPSS (Statistical Package for the Social Sciences) 21.0 program will be used to evaluate the obtained data. Data will be expressed as frequency distribution, percentage, mean ± standard deviation.
Tidsramme: 3 mounth
|
The assumption of sphericity will be assessed using Mauchly's sphericity test.
Overall differences between groups will be determined using the Kruskal-Wallis test for quantitative variables and the chi-square test for level of awareness, level of cognitive function, and basic cognitive sensory recovery.
The independent samples t-test, a parametric test used for comparing groups, or the Mann Whitney U test, a non-parametric test, will be used for comparisons between groups.
The significance level will be set at p<0.05.
|
3 mounth
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 10.03.2025/85
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- SEVJE
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