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

NCT05403515 | Completed

• 1 other identifier: Osmaniye Korkut Ata Unıvesity
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Foot massage; Aromatherapy massage; Happiness; Sleep quality; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lavender oil inhalation changes happiness and sleep quality

  1 month

Study Arms (3)

Control group

NO INTERVENTION

Routine nursing interventions were performed on the patients.

Foot massage group:

EXPERIMENTAL

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 +Aromatherapy group:

EXPERIMENTAL

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

Interventions

foot massage OTHER

foot massage

Foot massage group:

Foot massage +Aromatherapy group OTHER

foot massage and lavender oil inhalation

Foot massage +Aromatherapy group:

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (1)

Sercan Altın

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke; Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevser Sevgi Ü ASLAN

  OSMANİYE KORKUT ATA UNİVERSİTY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 3, 2022
• Study Start: July 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

TU (1)