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CompletedNCT05892679acupressUpdated Jun 28, 2024

The Effect of Acupressure in Hemodialysis Patients

An interventional study of acupressure in Fatigue, Comfort and Quality of Life, sponsored by Mersin University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by Mersin University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. The study group (n=30) Acupressure is formulated according to the standards of the World Health Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the appropriate pressure intensity and duration. 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. Considering the anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be used for application to the relevant point. Successive compressions will be applied at a frequency that does not disturb the patient, does not cause pain, and has a calming effect. Considering the studies done, a person will be given acupressure three times a week for four weeks. No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups will be given an informative training on acupressure and fatigue, increase the quality of life and comfort level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of acupuncture on quality of life and comfort level in hemodialysis patients.

The results will be collected before the acupressure and in the 4th week of the last intervention.

02

Conditions studied

  • Fatigue
  • Comfort
  • Quality of Life

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Keywords

  • acupressure
  • hemodialysis patients
  • Fatigue
  • Comfort
  • Quality of Life
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 60 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Mersin University is the lead sponsor of 173 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Acupressure

    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

  • No intervention
    Control

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

Interventions

  • Otheracupressure

    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.

06

What researchers measure

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.

    Time frame: Change from before implementation and 4th week of practice

Secondary outcomes

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

    Scores on each dimension range from 0 to 100, with higher scores reflecting better health related quality of life.

    Time frame: Change from before implementation and 4th week of practice

  2. Comfort to be evaluated using Hemodialysis Comfort Scale

    The score that can be obtained from the scale varies between 9 and 45. There is an inverse item in the scale.

    Time frame: Change from before implementation and 4th week of practice

07

Study locations

1 site
  • Turkey Mersin University
    Mersin, Turkey
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 12, 2023
  • Informed consent form · Jun 12, 2023
  • Informed consent form · Jun 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data will not be used outside of this research.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05892679
Lead sponsor
Mersin University
Responsible party
VECİHE DÜZEL GÜNDÜZ (MSN Nurse, Mersin University) — Principal investigator
First posted
Jun 7, 2023
Start date
May 30, 2023
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Last update
Jun 28, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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