The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp

NCT04874857 | Completed

• 2 other identifiers: Erciyes UniversityPhD student
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled and single-blind study consisting of qualitative and quantitative stages to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in crampy hemodialysis (HD) patients.

Conditions

Muscle Cramps; Aromatherapy; Hemodialysis; Quality of Life; Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scala (VAS)

  The widespread use of VAS, which has been used in the research of subjective concepts from past years to the present, has been realized after in 1969. This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. The patient marks the severity of the cramp he is experiencing at that moment, and the starting and ending points of the scale as criteria. A VAS value between 1-3 means "mild pain", between 4-6 means "moderate pain", and a value between 7-10 means "severe pain". Participants will mark the scale each time they experience a cramp.

  During 1 month

Secondary Outcomes (1)

• Quality of Life Index Dialysis Version - III

  At the first and last meeting in 1 month

Study Arms (3)

Intervention group (Aromatherapy group)

EXPERIMENTAL

With a mixture of Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. essential oils, the foot and lower leg will be massaged for three sessions a week for 30 minutes in each session for four weeks.

Other: Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.

Placebo group

EXPERIMENTAL

The foot and lower leg will be massaged with baby oil for four weeks, three sessions a week, 30 minutes in each session.

Other: Baby oil

Control group

NO INTERVENTION

No application will be made in addition to standard HD treatment.

Interventions

Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. OTHER

Massage application

Intervention group (Aromatherapy group)

Baby oil OTHER

Massage application

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years old,
• Able to answer questions and communicate,
• Is conscious and does not have a mental problem,
• Speaks Turkish,
• No hearing, sight or speech impairment,
• Having HD treatment for at least six months,
• Receiving three HD treatment sessions a week,
• Dialysis with bicarbonate dialysate,
• Kt / V value\> 1.2,
• Having a constant dry weight for the last month,
• Experiencing cramps during hemodialysis sessions or at any other time and who scored at least three or more when the severity of cramp pain was evaluated with the Visual Analog Scale (VAS),
• Patients who are not allergic to the oils used for massage will be included in the study.

You may not qualify if:

• Pregnant and breastfeeding women,
• Cancer,
• Diabetic foot,
• Lower extremity amputation,
• Having neurological diseases such as epilepsy, parkinson, dementia, Alzheimer,
• Those with paraplegia,
• The lower leg is in a size that prevents the application of massage,
• had surgery in the last three months,
• Loss of sensation more than 50% due to neuropathy due to various reasons,
• Open wound in the foot and lower leg, infection, necrosis, fracture / fracture suspected, soft tissue damage, burn,
• Peripheral vascular disease,
• Deep vein thrombosis,
• Receiving treatment to prevent cramping,
• Having a severe electrolyte (such as potassium, magnesium, calcium) disorder in blood values,
• Patients using any of the complementary and integrated methods in the last month will not be included in the study.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, 38260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Cramp; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serife Cetin, PhD

  Kayseri University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 6, 2021
• Study Start: November 25, 2020
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)