- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07593430
The Effect of Aromatherapy Massage-Based Sensory Stımulatıon Program on Cognıtıve and Sensory Functıon ın Intensıve Care Patıents
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: nilgün erdoğan
- Telefoonnummer: +905312599220
- E-mail: nilgunerdogan37@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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,
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: group that applied
aromatherapy
|
Sensory stimulation program performed by a family member of the patient using aromatherapy massage.
|
|
Placebo-vergelijker: intervention 2
lavender
|
Sensory stimulation program performed by a nurse using aromatherapy massage.
|
|
Placebo-vergelijker: plasebo group
control
|
routine nursing practice
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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).
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 10.03.2025/85
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD-tijdsbestek voor delen
IPD delen Ondersteunend informatietype
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .