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

July 10, 2022 updated by: Zülfünaz ÖZER, Istanbul Sabahattin Zaim University

The Effect of Self-Acupressure on Pain, Fatigue and Sleep Quality in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 340340
        • Recruiting
        • Istanbul Sabahattin Zaim University, Faculty of Health Sciences
        • Principal Investigator:
          • Gülcan Bahçecioğlu Turan, PhD
        • Sub-Investigator:
          • Nurdan Şahin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Self-Acupressure
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
Other: Self-Acupressure
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.
NO_INTERVENTION: Control group
Routine maintenance will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: At the end of Sessions 1 (each Session 2 days a week).
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
Time Frame: At the end of Sessions 16 (each Session 2 days a week).
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
Time Frame: At the end of Sessions 1 (each Session 2 days a week).
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
Time Frame: At the end of Sessions 16 (each Session 2 days a week).
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
Time Frame: At the end of Sessions 1 (each Session 2 days a week).
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
Time Frame: At the end of Sessions 16 (each Session 2 days a week).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Sabahattin Zaim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 4, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 10, 2022

First Posted (ACTUAL)

July 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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