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TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS

Primary Purpose

TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TENS, Distractive techniques, cryotherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1-Inclusion criteria:

    1. Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
    2. At least one year passed from the installation of AVF and hemodialysis.
    3. Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
    4. Having no traces of skin abnormalities or analgesia in vessels access point.

Exclusion Criteria:

  • 2-Exclusion Criteria:

The following were considered exclusion criteria:

  1. Unwillingness to continue with the study.
  2. Unsuccessful AVF cannulation at the first try.
  3. Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
  4. Presence of infection and obstruction of fistula based on the nurse's inspection.
  5. The presence of auditory and visual disturbances.
  6. history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis.
  7. Having traces of severe pain in other parts.
  8. Having pacemakers

Sites / Locations

  • Hemodialysis unit, General Ashmoon HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

• Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).

•Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy)

• Group (3) will receive (cryotherapy and conventional physical therapy program).

Arm Description

Outcomes

Primary Outcome Measures

The KDQOL-36, Numerical Rating Scale for pain measurement
Numerical Rating Scale of Pain Severity is numbered between 0 and 10 indicating positive and negative pain statements, respectively. Accordingly, the rating of this scale was 0 (lack of pain), 1-3 (low pain), 4-6 (moderate pain), 7-9 (severe pain), and 10 (very severe pain). The Cronbach's alpha coefficient for this tool was reported as 0.95 and its reliability score using the intra-class correlation coefficient was 0.92 (Mirtajadini et al., 2016). The KDQOL-36: It is a 36-item health-related quality of life instrument adapted from the original 134-item KDQOL, an instrument principally developed to measure quality of life of dialysis patients [25].

Secondary Outcome Measures

Full Information

First Posted
July 27, 2022
Last Updated
July 27, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05480397
Brief Title
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS
Official Title
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Statement of the problem: This study will be conducted to answer the following question: Is there a difference in the efficacy of TENS and distractive techniques when combined with cryotherapy in managing pain due to arteriovenous fistula puncture and improving quality of life in hemodialysis patients ? Null Hypotheses: TENS has no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture. Distractive techniques have no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture. There is no statistically significant difference between TENS and distractive techniques in managing pain and improving quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
Detailed Description
Subjects' Selection: The patients will be randomly assigned to 3 groups; Group (1) will receive (TENS , cryotherapy and conventional physical therapy program). Group (2) will receive (distractive techniques , cryotherapy and conventional physical therapy program). Group (3) will receive (cryotherapy and conventional physical therapy program). Patients will be assessed for quality of life before and after treatment and will receive 3 sessions per week consisted of TENS, distractive techniques , Cryotherapy and conventional physical therapy program during AVF Puncture during dialysis for 4 weeks. 1-Inclusion criteria: Patient age will range from 20 - 60 years who have chronic renal failure from males and females. At least one year passed from the installation of AVF and hemodialysis. Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours. Having no traces of skin abnormalities or analgesia in vessels access point. 2-Exclusion Criteria: The following were considered exclusion criteria: Unwillingness to continue with the study. Unsuccessful AVF cannulation at the first try. Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation. Presence of infection and obstruction of fistula based on the nurse's inspection. The presence of auditory and visual disturbances. history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis. Having traces of severe pain in other parts. Having pacemakers. The patients will be randomly assigned to 3 groups; Group(1) will receive TENS , cryotherapy and conventional physical therapy program, Group(2) will receive distractive techniques , cryotherapy and conventional physical therapy program and Group(3) will receive cryotherapy and conventional physical therapy program. All groups will be assessed for quality of life using Kidney Disease Quality of Life Short Form Scale (KDQOL-SF) before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
• Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).
Arm Type
Experimental
Arm Title
•Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy)
Arm Type
Experimental
Arm Title
• Group (3) will receive (cryotherapy and conventional physical therapy program).
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
TENS, Distractive techniques, cryotherapy
Intervention Description
Group (1): Will receive (TENS , cryotherapy and conventional physical therapy ) Massage with ice was done by the researcher over the AVF puncture site . After that, the TENS electrodes will be applied by the researcher 6 centimeters apart closely up and down the skin area for insertion of the needle. Group (2): Will receive (Distraction techniques ,cryotherapy and conventional physical therapy ) Initially five minutes before starting hemodialysis, Distraction techniques will be applied. Natural and eye-catching images were broadcasted through a video display device on a laptop monitor in a manner that was easy for the older patient to watch while they were lying on the bed. Massage with ice was done by the researcher over the AVF puncture site Group (3): Will receive (cryotherapy and conventional physical therapy )
Primary Outcome Measure Information:
Title
The KDQOL-36, Numerical Rating Scale for pain measurement
Description
Numerical Rating Scale of Pain Severity is numbered between 0 and 10 indicating positive and negative pain statements, respectively. Accordingly, the rating of this scale was 0 (lack of pain), 1-3 (low pain), 4-6 (moderate pain), 7-9 (severe pain), and 10 (very severe pain). The Cronbach's alpha coefficient for this tool was reported as 0.95 and its reliability score using the intra-class correlation coefficient was 0.92 (Mirtajadini et al., 2016). The KDQOL-36: It is a 36-item health-related quality of life instrument adapted from the original 134-item KDQOL, an instrument principally developed to measure quality of life of dialysis patients [25].
Time Frame
one hour for each participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1-Inclusion criteria: Patient age will range from 20 - 60 years who have chronic renal failure from males and females. At least one year passed from the installation of AVF and hemodialysis. Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours. Having no traces of skin abnormalities or analgesia in vessels access point. Exclusion Criteria: 2-Exclusion Criteria: The following were considered exclusion criteria: Unwillingness to continue with the study. Unsuccessful AVF cannulation at the first try. Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation. Presence of infection and obstruction of fistula based on the nurse's inspection. The presence of auditory and visual disturbances. history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis. Having traces of severe pain in other parts. Having pacemakers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal Abdlmohsen Abdelhakim, physical therapist
Phone
2001092123253
First Name & Middle Initial & Last Name or Official Title & Degree
Amaal Hassan Ibrahim, professor of physical therapy
Phone
2001200861702
Email
aebrahim123@hotmail.com
Facility Information:
Facility Name
Hemodialysis unit, General Ashmoon Hospital
City
Ashmoon, Menofia
State/Province
Menofia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamal Abdlmohsen Abdelhakim, physical therapist
Phone
200102123253

12. IPD Sharing Statement

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TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS

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