Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT05823077
• Lead Sponsor: KTO Karatay University

Brief Summary

In this study, the effects of 4-week aromatherapy massage on pain, functionality, sleep quality and menopausal symptoms will be examined in individuals diagnosed with knee osteoarthritis during menopause.

Detailed Description

The aim of this study is to investigate the effect of aromatherapy massage performed with bergamot oil for 4 weeks on pain, function, sleep and menopausal symptoms in menopausal women with knee osteoarthritis. Participants will be randomly divided into 3 groups as Bergamot, placebo and control. In addition to the conventional treatment, the Bergamot group will receive 2 sessions of Bergamot oil per week for 4 weeks, and the placebo group will be massaged with 2 sessions of sweet almond oil for 4 weeks. the control group will continue conventional treatment for 4 weeks. All assessments will be performed before starting treatment and at the end of 4 weeks of treatment. Participants' pain will be evaluated by VAS, Functions by WOMAC, Sleep quality by PSQI, menopausal symptoms by Menopause Symptoms Evaluation scale. At the end of the study, the satisfaction of the participants will be evaluated with VAS.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-08
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-21
• Study Start: 2023-05-24
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-13
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Being between the ages of 40-65,
• having entered the menopause,
• being diagnosed with knee OA,
• being at the level of OA 2-3,
• having pain at rest in the knee VAS ≥ 4.

Exclusion Criteria

• Any knee surgery
• known allergies to the oils to be used

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain at 4 weeks	Baseline and 4 weeks	The rest, activity and night pains of the participants will be evaluated with a 10 cm Visuak Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in menopause symphtoms at 4 weeks	Baseline and 4 weeks	Participants' menopausal symptoms will be evaluated with the Menopause Symptoms Evaluation Scale. Higher scores indicate more menopausal symptoms. Evaluations will be made before the study and after 4 weeks of practice.
Change from baseline in function at 4 weeks	Baseline and 4 weeks	Participants' functions will be evaluated with Western Ontario and McMaster Universities Osteoarthritis Index. A minimum of "0" points and a maximum of "96" points can be obtained on the scale. High scores indicate high impairment and limitation of functional status and poor quality of daily life. Evaluations will be made before the study and after 4 weeks of practice.
Patients satisfaction after the interventions	4 weeks	Participants' satisfaction with the treatment over pain and function will be evaluated with Visual Analog Scale. Higher score indicate more satisfaction. Evaluation will take place after 4 weeks of study.
Change from baseline in sleep quality at 4 weeks	Baseline and 4 weeks	The sleep quality of the participants will be evaluated with Pittsburgh Sleep Quality Index . The total score is between 0-21. High scores indicate poor sleep quality. Evaluations will be made before the study and after 4 weeks of practice.

Trial Locations

Locations (1)

KTO Karatay University; 🇹🇷 Konya, Karatay, Turkey