| Registry | NCT07593430 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, health services research |
| Enrollment | 60 (Estimated) |
| Sponsor | Nigde Omer Halisdemir University (Other) |
| Conditions | Cognitive Sensory Perception Level, in Unconscious Patients, Lung Disaases, Cerebro Vascular Disease, Trauma Patients |
| Interventions | Intervention 1, Intervention 2, plasebo group (Behavioral) |
| Dates | start 2026-06-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-05-18, last updated 2026-05-18 |
Related Papers Related Patents Related Grants Related Experts
All trials for Cognitive Sensory Perception Level All trials for in Unconscious Patients All trials of Intervention 1 All trials of Intervention 2
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| group that applied | Active comparator | Behavioral: Intervention 1 | aromatherapy |
| intervention 2 | Placebo comparator | Behavioral: Intervention 2 | lavender |
| plasebo group | Placebo comparator | Behavioral: plasebo group | control |
Sex: All, ages: 18 Years to 90 Years, accepts healthy volunteers
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,