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

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
foot massage
Foot massage +Aromatherapy group
Sponsored by
Osmaniye Korkut Ata University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Foot massage, Aromatherapy massage, Happiness, Sleep quality, Fatigue

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sercan Altın

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Foot massage group:

Foot massage +Aromatherapy group:

Arm Description

Routine nursing interventions were performed on the patients.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2022
Last Updated
May 31, 2022
Sponsor
Osmaniye Korkut Ata University
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1. Study Identification

Unique Protocol Identification Number
NCT05403515
Brief Title
Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Official Title
Effects of Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osmaniye Korkut Ata University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Foot massage, Aromatherapy massage, Happiness, Sleep quality, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine nursing interventions were performed on the patients.
Arm Title
Foot massage group:
Arm Type
Experimental
Arm Description
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.
Arm Title
Foot massage +Aromatherapy group:
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
foot massage
Intervention Description
foot massage
Intervention Type
Other
Intervention Name(s)
Foot massage +Aromatherapy group
Intervention Description
foot massage and lavender oil inhalation
Primary Outcome Measure Information:
Title
foot massage changes improves happiness and sleep quality.
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Lavender oil inhalation changes happiness and sleep quality
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevser Sevgi Ü ASLAN
Organizational Affiliation
OSMANİYE KORKUT ATA UNİVERSİTY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sercan Altın
City
Adana
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data can be shared if the author gives consent for appropriate reasons.

Learn more about this trial

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

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