Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

NCT ID: NCT05823077

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2023-08-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bergamot

In addition to 4 weeks of conventional treatment, Bergamot oil diluted with 1.5% sweet almond oil (4 drops of aromatic oil to 10 cc of sweet almond oil) will be used on the participants. After the oil is diluted, it will be heated up to 36oC. The participant will sit on the stretcher directly opposite the therapist, with the affected knee semi-flexed. The therapist will massage the affected knee for 15 minutes. After the massage, the knees will be wrapped with a towel for 5 minutes.

Group Type EXPERIMENTAL

Bergamot

Intervention Type OTHER

The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.

Placebo

In addition to 4 weeks of conventional treatment, Pure sweet almond oil will be used for the participants. Sweet almond oil will be heated to 36oC. The participant will sit on the stretcher directly opposite the therapist, with the affected knee semi-flexed. The therapist will massage the affected knee for 15 minutes. After the massage, the knees will be wrapped with a towel for 5 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.

Control

4 weeks of conventional treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bergamot

The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.

Intervention Type OTHER

Placebo

The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KTO Karatay University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KaratayUH8

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Moxibustion in Osteoarthritis of the Knee
NCT02769572 COMPLETED PHASE3
WHIRLPOOL FOR OSTEOARHRITIS
NCT03299114 COMPLETED NA