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

NCT07593430 | Not Yet Recruiting DMC

• 1 other identifier: 10.03.2025/85
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Disaases; Cerebro Vascular Disease; Trauma Patients; Cognitive Sensory Perception Level; in Unconscious Patients

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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.

  3 mounth

Study Arms (3)

group that applied

ACTIVE COMPARATOR

aromatherapy

Behavioral: Intervention 1

intervention 2

PLACEBO COMPARATOR

lavender

Behavioral: Intervention 2

plasebo group

PLACEBO COMPARATOR

control

Behavioral: plasebo group

Interventions

Intervention 1 BEHAVIORAL

Sensory stimulation program performed by a family member of the patient using aromatherapy massage.

group that applied

Intervention 2 BEHAVIORAL

Sensory stimulation program performed by a nurse using aromatherapy massage.

intervention 2

plasebo group BEHAVIORAL

routine nursing practice

plasebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with acute brain injury,
• Glasgow Coma Score (GCS) between 6 and 12,
• Intubated or monitored on oxygen,
• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Central Study Contacts

nilgün erdoğan

CONTACT

+905312599220; nilgunerdogan37@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 1 year