Self-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus

NCT05453422 | Unknown

• 1 other identifier: 8990
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

Fatigue; Pain; Sleep quality; Systematic lupus erythemasus

Outcome Measures

Primary Outcomes (6)

• Visual Analog Scale

  The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.

  At the end of Sessions 1 (each Session 2 days a week).

• Visual Analog Scale

  The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.

  At the end of Sessions 16 (each Session 2 days a week).

• The Piper Fatigue Scale

  The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.

  At the end of Sessions 1 (each Session 2 days a week).

• The Piper Fatigue Scale

  The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.

  At the end of Sessions 16 (each Session 2 days a week).

• The Richards-Campbell Sleep Questionnaire

  This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.

  At the end of Sessions 1 (each Session 2 days a week).

• The Richards-Campbell Sleep Questionnaire

  This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.

  At the end of Sessions 16 (each Session 2 days a week).

Study Arms (2)

Self-Acupressure

EXPERIMENTAL

Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)

Other: Self-Acupressure

Control group

NO INTERVENTION

Routine maintenance will be applied.

Interventions

Self-Acupressure OTHER

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 order to ensure the continuation and balance of the energy in our body.

Self-Acupressure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, 340340, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 33144299 RESULT

• 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.

  PMID: 18306446 RESULT

MeSH Terms

Conditions

Sleep Wake Disorders; Fatigue; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Zülfünaz Özer, PhD

  Istanbul Sabahattin Zaim University

  STUDY DIRECTOR

Central Study Contacts

Zülfünaz Özer, PhD

CONTACT

05379537007; zulfinazozer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Self-Acupressure and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: This study is an experimental study with pre-test and post-test control groups

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: July 4, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)