NCT05892679

Brief Summary

This randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

May 27, 2023

Last Update Submit

June 27, 2024

Conditions

Keywords

acupressurehemodialysis patientsFatigueComfortQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Fatigue to be evaluated using the Piper Fatigue Scale

    The total score obtained from the scale varies between 0 and 10 and as the score increases, the fatigue experienced by the individuals increases.

    Change from before implementation and 4th week of practice

Secondary Outcomes (2)

  • Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)

    Change from before implementation and 4th week of practice

  • Comfort to be evaluated using Hemodialysis Comfort Scale

    Change from before implementation and 4th week of practice

Study Arms (2)

Acupressure

EXPERIMENTAL

Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks.

Other: acupressure

Control

NO INTERVENTION

No intervention will be made to the control group only the data will be collected at the same time as the study group.

Interventions

Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks.

Acupressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written and verbal consent was obtained to participate in the study,
  • Can read, write, speak and understand Turkish,
  • Are older than 18 years,
  • Have received HD treatment for at least 6 months,
  • Receiving HD treatment 3 times a week,
  • Fatigue severity ≥4, using a single-item fatigue index ranging from 0 to 10 points,
  • Absence of lower extremity wounds
  • Any complementary therapy
  • Conscious, fully oriented and cooperative and open to communication,
  • No visual, hearing and perception problems,
  • Any psychiatric patient

You may not qualify if:

  • Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture
  • Any psychiatric disease,
  • Patients with hepatitis B and hepatitis C,
  • Using any of the complementary and integrated methods
  • Those who receive HD treatment twice a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researcher cannot be blinded due to the nature of the research. However, participants will be blinded without knowing whether they are in the study group or the placebo group. Thus, the research will be carried out as a single-blind randomized controlled trial. When the research is completed, the data of the study and control groups (coded as A or B) will be transferred to the computer environment by an independent researcher, and the data will be analyzed by a statistician and the findings will be reported.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSN Nurse

Study Record Dates

First Submitted

May 27, 2023

First Posted

June 7, 2023

Study Start

May 30, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be used outside of this research.

Locations