Effect of Acupressure on Fatigue in Hemodialysis Patients

NCT05571007 | Completed

• 1 other identifier: 3010/KEPK/VII/2019
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE: To investigate the effect of acupressure on fatigue in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD) as well as assess sleep quality and psychological status HYPOTHESIS TO BE TESTED: Upon intervention completion, the experimental group will exhibit lower severity of fatigue and depression/anxiety and improved sleep quality compared to the control group. DESIGN AND SUBJECTS: A randomized controlled trial with experimental and control groups. A total of 116 patients with ESRD who screen positive for fatigue severity ≥ 4 (using a single-item indicator of fatigue, which ranges from 0 to 10 points) will be recruited. STUDY INSTRUMENTS: Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS) INTERVENTION: A 4-week acupressure intervention was performed by the principal investigator (PI) for every subject by applying the rate of two rotations per second, three times a week. MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, depression, and anxiety. DATA ANALYSIS: Multiple regression was used to analyze between-group differences in BFI and PSQI, while ordinal logistic regression was used to analyze the subscales of the HADS. EXPECTED RESULTS: The proposed acupressure intervention is useful for alleviating fatigue and related symptoms (sleep quality, depression, and anxiety) experienced by patients with ESRD.

Conditions

End-stage Renal Disease

Keywords

End-stage renal disease; Hemodialysis; Acupressure; Fatigue; Sleep; Anxiety/depression

Outcome Measures

Primary Outcomes (2)

• Brief Fatigue Inventory (BFI)

  A questionnaire will be used to measure the severity of fatigue in the past 24 hours. This 9-item self-reported questionnaire is scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively. The BFI score is classified into mild (1-3 points), moderate (4-6 points), and severe fatigue (7-10 points).

  Before the intervention (baseline, T0)

• Brief Fatigue Inventory (BFI)

  A questionnaire will be used to measure the severity of fatigue in the past 24 hours. This 9-item self-reported questionnaire is scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively. The BFI score is classified into mild (1-3 points), moderate (4-6 points), and severe fatigue (7-10 points).

  Completion of the 4-week intervention (post-test, T1)

Secondary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  Before the intervention (baseline, T0)

• Pittsburgh Sleep Quality Index (PSQI)

  Completion of the 4-week intervention (post-test, T1)

• Hospital Anxiety and Depression Scale

  Before the intervention (baseline, T0)

• Hospital Anxiety and Depression Scale

  Completion of the 4-week intervention (post-test, T1)

Study Arms (2)

True acupressure

EXPERIMENTAL

Using three true acupoints. Acupoints: Yongquan (K1), Sayingjiao (SP6), Zusanli (ST36). Patient Position: Lying or sitting position. Time: first 2 hours of HD.

Other: True acupressure

Sham acupressure

SHAM COMPARATOR

Using three sham acupoints. Acupoints: Sham acupoints are located on 1 cun from the true acupoint. Patient Position: Lying or sitting position. Time: first 2 hours of HD.

Other: Sham acupressure

Interventions

True acupressure OTHER

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.

True acupressure

Sham acupressure OTHER

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.

Sham acupressure

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≧ 18 years
• \. HD therapy for at least 3 months
• \. Experience of fatigue (fatigue severity ≥ 4, using a single-item indicator of fatigue, ranging from 0 to 10 points)
• \. Absence of lower limb wounds
• \. Did not receive any complementary treatment

You may not qualify if:

• \. Diagnosis of major depression or psychiatric disorders
• \. Wound or amputation of the lower extremities, rheumatoid arthritis, or limb fracture

Sponsors & Collaborators

• Woung-Ru Tang: lead
• Harapan Bangsa University: collaborator
• RS Prof. Dr. Margono Soekardjo Purwokerto: collaborator

Study Sites (1)

RS Prof Dr Margono Soekardjo Purwokerto

Purwokerto, Central Java, Indonesia

Location

Related Publications (1)

• Suandika M, Chen SY, Fang JT, Yang SH, Tsai YF, Weng LC, Tsay PK, Tang WR. Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-Blinded Randomized Controlled Trial. J Integr Complement Med. 2023 Feb;29(2):111-118. doi: 10.1089/jicm.2022.0644. Epub 2022 Nov 22.

  PMID: 36413013 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Fatigue; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Made Suandika, PhDCandidate

  School of Nursing, Harapan Bangsa University, Central Java, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 7, 2022
• Study Start: July 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

ID (1)