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The Effect of Aromatherapy Massage-Based Sensory Stımulatıon Program on Cognıtıve and Sensory Functıon ın Intensıve Care Patıents

13. mai 2026 oppdatert av: Nilgün Erdoğan, Nigde Omer Halisdemir University
Background: Sensory stimulation is a treatment that uses auditory, visual, tactile, gustatory, and olfactory stimuli, as well as balance and position modes, with intensity and frequency adjusted to the patient's individual thresholds to increase the frequency of arousal, awareness, and pronounced behavioral responses. Studies have shown that sensory stimulation, especially when applied from the beginning of the patient's hospitalization, can shorten the average length of stay and reduce patient anxiety. Among the TIT methods applied by nurses, touch, music therapy, and aromatherapy are included as applications that can be applied to the sensory input problems of intensive care patients and can positively affect their sensory perceptions.Objective: This study is planned to be conducted as a randomized controlled single-blind study to determine the effect of a sensory stimulation program performed with aromatherapy massage applied twice daily for 7 days with a mixture of orange, patchouli, and rosemary oil (7 drops of sweet orange oil, 5 drops of patchouli oil, and 3 drops of rosemary oil in 50 ml of jojoba oil) on the cognitive sensory perception level of patients monitored on mechanical ventilation or oxygen in the ICU.Method: In the study, all patients hospitalized in the tertiary care ICU of the University's Training and Research Hospital will constitute the population. Randomized sampling method will be used in the study. Sample size; G*power 3.5.1. In the power analysis performed with the software package, it is planned that each group will consist of at least 20 people to determine an effect size of 1% with an alpha risk of 0.05 and a power of 0.80 in line with the literature. The data collection tools to be used are: Patient Identification Form, Patient Monitoring Form, Medication Monitoring Form, Glasgow Coma Scale, Rancho Los Amigos Cognitive Function Scale. In Intervention Group 1, massage will be performed by the lead researcher ICU nurse, and the sensory stimulation program will be performed by a trained family member. In Intervention Group 2, massage will be performed by the lead researcher ICU nurse, and the sensory stimulation program will be performed by a nurse. Routine care will be provided to the control group. Since the groups are compared, the independent samples t-test and the Shapiro-Wilk test, which are parametric tests, will be used for evaluation.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

26. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

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)?

JA

IPD-delingstidsramme

1 year

IPD-deling Støtteinformasjonstype

  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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