Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke

Stroke, Ischemic Clinical Trial

Official title:

Effects of Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403515
• Other study ID #: Osmaniye Korkut Ata Univesity
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: May 2022
• Source: Osmaniye Korkut Ata University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world.

Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke.

Material and method: The present study is a randomized clinical study with a control group. Participants were randomly divided into three groups (foot massage + aromatherapy, aromatherapy, and control). The study was carried out with 91 patients diagnosed with stroke. The data were collected using Sociodemographic Status Survey, Oxford Happiness Questionnaire, Piper Fatigue Scale, Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were performed using SPSS (IBM SPSS Statistics 24) package program. The results were interpreted using frequency tables and descriptive statistics. Foot massage group was given 30min foot massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was given lavender oil inhaler during the foot massage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria were diagnosis of stroke at least 3 months, stroke levels of mild or moderate, no use of sleeping pill, volunteering in participation, not being allergic to aromatic oils, no problem with sense of smell, and no lung problem

Exclusion Criteria:

• Exclusion criteria were ulceration or lesion problem in foot, bone deformation in foot, history of allergy, cognitive or mental or language problems, difficulty in verbal communication, psychotic disorders, and not knowing the Turkish language.

Related Conditions & MeSH terms

• Fatigue
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• foot massage
foot massage
• Foot massage +Aromatherapy group
foot massage and lavender oil inhalation

Locations

Country	Name	City	State
Turkey	Sercan Altin	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Osmaniye Korkut Ata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	foot massage changes improves happiness and sleep quality.	Oxford Happiness Questionnaire - Short Form (OHQ - S) The total score ranges between 7 and 35 points.; Pittsburgh Sleep Quality Index (PSQI): To identify the sleep is good or bad, PSQI quantitatively measures the quality of sleep. It includes a total of 24 items. Total score of 0-4 points indicates a good sleep quality and the scores between 5 and 21 indicate a poor sleep quality Piper Fatigue Scale Developed by Piper et al. (1998), this scale consists of 24 items and assesses 4 subjective dimensions of fatigue. Reliability and validity of Piper Fatigue Scale for Turkish society were tested by Can (2001). The mean score of 0 point indicates that there was no fatigue, whereas mean scores between 1 and 3 indicate a mild level of fatigue, those between 4 and 6 indicate a moderate level of fatigue, and those between 7 and 10 indicate a severe level of fatigue	1 month
Secondary	Lavender oil inhalation changes happiness and sleep quality	Oxford Happiness Questionnaire - Short Form (OHQ - S) The total score ranges between 7 and 35 points.; Pittsburgh Sleep Quality Index (PSQI): To identify the sleep is good or bad, PSQI quantitatively measures the quality of sleep. It includes a total of 24 items. Total score of 0-4 points indicates a good sleep quality and the scores between 5 and 21 indicate a poor sleep quality Piper Fatigue Scale Developed by Piper et al. (1998), this scale consists of 24 items and assesses 4 subjective dimensions of fatigue. Reliability and validity of Piper Fatigue Scale for Turkish society were tested by Can (2001). The mean score of 0 point indicates that there was no fatigue, whereas mean scores between 1 and 3 indicate a mild level of fatigue, those between 4 and 6 indicate a moderate level of fatigue, and those between 7 and 10 indicate a severe level of fatigue	1 month