The Effect of Aromatherapy Massage on Sleep Quality

NCT06295900 | Recruiting

• 1 other identifier: 19.10.2023/63
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality.

Conditions

Diabetes Mellitus; Respiratory Failure; Pneumonia; Respiratory Disease; Stroke, Ischemic

Keywords

intensive care; sleep quality; aromatherapy massage

Outcome Measures

Primary Outcomes (1)

• Patient Introduction Form

  In the "Patient Introduction Form" prepared by the researcher based on the literature in order to obtain information about the characteristics of the patients who will constitute the sample, the patients' medical diagnosis, age, gender, chronic diseases, length of stay in intensive care, use of analgesic, sedative and hypnotic drugs used, normal sleep hours at night were included. There are questions about (sleep duration, daytime sleep, sleep hours, sleep aids used, etc.).

  1 year

Secondary Outcomes (1)

• Patient Follow-up Form

  1 year

Other Outcomes (1)

• Visual Comparison Sleep Scale

  1 year

Study Arms (3)

Intervention 1 Group

ACTIVE COMPARATOR

In this group, application is made with chamomile, lavender and neroli oil.

Other: Intervention 1 Group

Intervention 2 Group

SHAM COMPARATOR

In this group, application is made with lavender oil.

Other: Intervention 2 Group

Placebo Control Group

PLACEBO COMPARATOR

In this group, application is made only with almond oil.

Other: Placebo Control Group

Interventions

Intervention 1 Group OTHER

20 patients were included in this group and aromatherapy was applied once a day, for a total of 30 minutes, for three days, with a mixture of lavender, medicinal chamomile, and neroli oil (2 drops of lavender oil, 4 drops of medicinal chamomile, 6 drops of neroli oil in 20 ml of sweet almond oil). Massage is planned.

Intervention 1 Group

Intervention 2 Group OTHER

It is planned to include 20 patients in this group and perform an aromatherapy massage with a mixture of only lavender oil (12 drops of lavender oil in 20 ml of sweet almond oil), once a day for three days, for a total of 30 minutes.

Intervention 2 Group

Placebo Control Group OTHER

It is planned to include 20 patients in this group and perform an aromatherapy massage with only almond oil (20 ml sweet almond oil) mixture, once a day for three days, for a total of 30 minutes.

Placebo Control Group

Eligibility Criteria

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

You may qualify if:

• years of age and over,
• Conscious patients,
• Staying in intensive care for 24 hours or more,
• Those with stable hemodynamic status,
• Receiving O2 therapy,
• Intubated patients, patients who have passed 24 hours after being extubated,
• Those whose saturation level is 85 and above

You may not qualify if:

• Patients with peripheral neuropathy or quadriplegia,
• Patients with open wounds on their body,
• Patients receiving analgesia and sedation infusion,
• Patients who are sedated,
• Patients in delirium,
• Patients with allergies detected before starting the application

Sponsors & Collaborators

• Nilgün Erdoğan: lead

Study Sites (1)

Ömer Halisdemir University Training and Research Hospital

Niğde, 51100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Respiratory Insufficiency; Pneumonia; Respiration Disorders; Ischemic Stroke; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It will be conducted as a randomized controlled single-blind study

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: March 6, 2024
• Study Start: January 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Locations

TU (1)