The Effect of Aromatherapy Massage on Sleep Quality

February 28, 2024 updated by: Nilgün Erdoğan

The Effect of Aromatherapy Massage Applied to Intensive Care Patients on Sleep Quality

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Nigde, Turkey, 51100
        • Recruiting
        • Ömer Halisdemir University Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention 1 Group
In this group, application is made with chamomile, lavender and neroli oil.
Other: Intervention 1 Group
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.
Sham Comparator: Intervention 2 Group
In this group, application is made with lavender oil.
Other: Intervention 2 Group
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.
Placebo Comparator: Placebo Control Group
In this group, application is made only with almond oil.
Other: Placebo Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Introduction Form
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Follow-up Form
Time Frame: 1 year
The patient follow-up form was created by the researcher and will include the visual comparison sleep scale follow-up results, the effects of the application (whether side effects develop, its effect on the application area, the patient's condition, etc.) and the dosage of the hypnotic and sedative drugs the patient took in the intensive care unit during the study. The sleep score results of the patients will be recorded on the patient follow-up form by the nurses who collected the data of the study the morning after the application (08), and the effects of the application will also be recorded by the researcher.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Comparison Sleep Scale
Time Frame: 1 year
It was first developed by Snyder-Halpern and Verran (1988) in 1987 to evaluate the sleep quality of sick and healthy individuals. The scale consists of 15 questions categorized under three subscales: 'discomfort' (interruptions and delays in sleep), 'effectiveness' (how good sleep rejuvenates the individual) and 'completion' (napping). Disturbance questions include: 1) waking in the middle of sleep, 2) waking after sleep onset, 3) movement during sleep, 4) firmness of sleep, 5) quality of discomfort, 6) sleep latency, and 7) quality of latency. Efficacy questions include: 1) recovery after awakening, 2) subjective sleep quality, 3) sleep adequacy assessment, 4) total sleep time, and 5) total sleep time, calculated by adding total sleep time and waking after sleep onset. Each question is scored using a 100 mm visual analogue scale. For the 'disruption' and 'completion' subscales, higher scores indicate sleep disturbance and lower scores indicate better sleep.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nilgün Erdoğan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.10.2023/63

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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