Clinical trial NCT05453422: Self-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus
Official title: The Effect of Self-Acupressure on Pain, Fatigue and Sleep Quality in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder
Keywords: Fatigue
Pain
Sleep quality
Systematic lupus erythemasus
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of Self-acupressure application on pain, fatigue and sleep quality in sle patients.

Detailed description: Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in our body in order to ensure the continuation and balance of the energy in our body.

Eligibility criteria: Inclusion Criteria:

* Being over the age of 18,
* Not using acupressure and similar integrative treatment methods,
* Not having a verbal communication disability (hearing and speaking),
* Not having a diagnosed psychiatric disorder,
* Not having a cognitive problem,
* Getting a score between 1-10 on the Piper Fatigue Scale,
* Getting a score between 1-10 on the VAS pain scale
* Agree to participate in the research.
* Not being in the active period of SLE (exacerbation in the last 3 months or not using steroids for 3 months)
* Not using other complementary and integrated health practices in the treatment process

Exclusion Criteria:

-

Primary outcomes:
measure: Visual Analog Scale
timeFrame: At the end of Sessions 1 (each Session 2 days a week).
measure: Visual Analog Scale
timeFrame: At the end of Sessions 16 (each Session 2 days a week).
measure: The Piper Fatigue Scale
timeFrame: At the end of Sessions 1 (each Session 2 days a week).
measure: The Piper Fatigue Scale
timeFrame: At the end of Sessions 16 (each Session 2 days a week).
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: At the end of Sessions 1 (each Session 2 days a week).
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: At the end of Sessions 16 (each Session 2 days a week).
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz Özer, PhD
role: STUDY_DIRECTOR
References:
citation: Aranow C, Atish-Fregoso Y, Lesser M, Mackay M, Anderson E, Chavan S, Zanos TP, Datta-Chaudhuri T, Bouton C, Tracey KJ, Diamond B. Transcutaneous auricular vagus nerve stimulation reduces pain and fatigue in patients with systemic lupus erythematosus: a randomised, double-blind, sham-controlled pilot trial. Ann Rheum Dis. 2021 Feb;80(2):203-208. doi: 10.1136/annrheumdis-2020-217872. Epub 2020 Nov 3.
citation: Wang T, Zhang Q, Xue X, Yeung A. A systematic review of acupuncture and moxibustion treatment for chronic fatigue syndrome in China. Am J Chin Med. 2008;36(1):1-24. doi: 10.1142/S0192415X08005540.