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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05403515
Recruitment Status : Completed
First Posted : June 3, 2022
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
Kevser Sevgi Ünal Aslan, Osmaniye Korkut Ata University

Brief 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.


Condition or disease Intervention/treatment Phase
Stroke, Ischemic Other: foot massage Other: Foot massage +Aromatherapy group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Actual Study Start Date : July 1, 2021
Actual Primary Completion Date : August 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Foot Health

Arm Intervention/treatment
No Intervention: Control group
Routine nursing interventions were performed on the patients.
Experimental: Foot massage group:
For the patients in this group, sociodemographic form, happiness questionnaire, and PSQI was applied as pretest in preliminary examination. The final examination was performed 1 month later (posttest) by using the same scale. For the patients in foot massage group, 30-min foot massage sessions (15 min for each foot, 3 sessions per week for 1 month) were performed in a special room of rehabilitation center, in a quiet atmosphere at suitable temperature and without environmental stimulants.
Other: foot massage
foot massage

Experimental: Foot massage +Aromatherapy group:
For the patients in this group, sociodemographic form, happiness questionnaire, and PSQI was applied as pretest in preliminary examination. The final examination was performed 1 month later (posttest) by using the same scale. During the foot massage + aromatherapy lavender inhalation intervention, the patients were given lavender oil for 30 minutes by using a censer. The intervention protocol was developed reviewing the literature about lavender oil inhalation
Other: Foot massage +Aromatherapy group
foot massage and lavender oil inhalation




Primary Outcome Measures :
  1. foot massage changes improves happiness and sleep quality. [ Time Frame: 1 month ]

    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



Secondary Outcome Measures :
  1. Lavender oil inhalation changes happiness and sleep quality [ Time Frame: 1 month ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05403515


Locations
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Turkey
Sercan Altın
Adana, Turkey
Sponsors and Collaborators
Osmaniye Korkut Ata University
Investigators
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Principal Investigator: Kevser Sevgi Ü ASLAN OSMANİYE KORKUT ATA UNİVERSİTY
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Responsible Party: Kevser Sevgi Ünal Aslan, assistant professor, Osmaniye Korkut Ata University
ClinicalTrials.gov Identifier: NCT05403515    
Other Study ID Numbers: Osmaniye Korkut Ata Unıvesity
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data can be shared if the author gives consent for appropriate reasons.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevser Sevgi Ünal Aslan, Osmaniye Korkut Ata University:
Foot massage
Aromatherapy massage
Happiness
Sleep quality
Fatigue
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Fatigue
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases