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Clinical Trials/NCT07593430
NCT07593430Not yet recruitingNot Applicable

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

Nigde Omer Halisdemir University0 sites60 target enrollmentStarted: June 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Primary Endpoint
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)

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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,

Arms & Interventions

group that applied

Active Comparator

aromatherapy

Intervention: Intervention 1 (Behavioral)

intervention 2

Placebo Comparator

lavender

Intervention: Intervention 2 (Behavioral)

plasebo group

Placebo Comparator

control

Intervention: plasebo group (Behavioral)

Outcomes

Primary Outcomes

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)

Time Frame: 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.

Secondary Outcomes

  • 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).(1 year)

Investigators

Sponsor
Nigde Omer Halisdemir University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nilgün Erdoğan

Principal Investigator

Nigde Omer Halisdemir University

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