The Effect of Aromatherapy Massage on Sleep Quality

NCT ID: NCT06295900

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Respiratory Failure Pneumonia Respiratory Disease Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It will be conducted as a randomized controlled single-blind study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention 1 Group

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

Group Type ACTIVE_COMPARATOR

Intervention 1 Group

Intervention Type 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 2 Group

In this group, application is made with lavender oil.

Group Type SHAM_COMPARATOR

Intervention 2 Group

Intervention Type 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.

Placebo Control Group

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

Group Type PLACEBO_COMPARATOR

Placebo Control Group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nilgün Erdoğan

OTHER

Sponsor Role lead

Responsible Party

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Nilgün Erdoğan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ömer Halisdemir University Training and Research Hospital

Niğde, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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nilgun erdogan, researcher

Role: primary

5312599220

Other Identifiers

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19.10.2023/63

Identifier Type: -

Identifier Source: org_study_id

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