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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04139759
Other study ID # massage
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2018
Est. completion date February 11, 2019

Study information

Verified date October 2019
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.


Description:

In parallel with the recent technological advances in medicine, increasing the possibilities of diagnosis and treatment of diseases has increased the average life expectancy and the incidence of chronic diseases. Chronic renal failure (CRF), which is one of the increasing chronic diseases, has become an important public health problem due to its negative impact on quality of life both in the world and in our country, high morbidity, mortality and treatment costs. According to the Joint Report of the Turkish Ministry of Health and Turkish Nephrology Association; by the end of 2016, Renal Replacement Therapy (RRT) applied total 74,475 patients (including pediatric patients), RRT is applied and while the most common form of treatment has been found to be hemodialysis treatment with 76.12%. Unless a successful renal transplantation is performed, hemodialysis treatment required to be performed until the end of life and provides a longer life, but it also causes biological, psychological, social and economical problems arising from treatment. Fatigue, which often related to problems with its biological dimension, reduces the quality of life by adversely negatively affecting individual's daily life activities.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date February 11, 2019
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- - Taking HD therapy, in the dialysis unit of a public hospital in Turkey, between October 19, 2018 - February 11, 2019,

- Agree to participate in the study with a written permission,

- Over the age of 18,

- Open to communication with complete orientation,

- Speaks and understands Turkish

- Receiving HD treatment 3 times a week for 6 months and longer,

- No loss of sensation, mass, fracture or ingrown toenail (onyxis),

- In the lower extremities; without pathological and tumoral disease, phlesis, embolism and no bleeding disorder related to amputation, fracture, infection, wound, skin disease, muscle and bones,

- Patients with a Standardized Mini Mental Test (SMMT) score of 24 or more, in patients older than 65 years,

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hand massage
In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.
foot massage
Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.

Locations

Country Name City State
Turkey Batman Regional State Hospital Batman

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ahmadidarrehsima S, Mohammadpourhodki R, Ebrahimi H, Keramati M, Dianatinasab M. Effect of foot reflexology and slow stroke back massage on the severity of fatigue in patients undergoing hemodialysis: A semi-experimental study. J Complement Integr Med. 20 — View Citation

Astroth KS, Russell CL, Welch JL. Non-pharmaceutical fatigue interventions in adults receiving hemodialysis: a systematic review. Nephrol Nurs J. 2013 Sep-Oct;40(5):407-27; quiz 428. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 4 Weeks Later/ 3rd Measurement At the end of the third week of the hand massage and foot massage applications, the third measurements were obtained by reapplying the Visual Similarity Scale for Fatigue scale to all three groups.In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high. thirtieth day
Primary Pre-Hemodialysis / 1st Measurement In addition to verbal and written information, the first measurements were obtained by applying the Patient Presentation Form, Visual Similarity Scale for Fatigue to the patients who were taken to hand massage, foot massage and control groups before HD treatment. In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high. first day
Secondary 2 Weeks Later /2nd Measurement At the end of the second week of the hand massage and foot massage applications, the second measurements were obtained by reapplying the Visual Similarity Scale for Fatigue scale to all three groups.In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high. fifteenth day
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