The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction

April 1, 2024 updated by: Ercan Bakır, Erzurum Technical University

The Effect of Ice Massage Applied Before Arteriovenous Fistula Cannulation Procedure on Pain, Ecchymosis, Hematoma and Patient Satisfaction in Hemodialysis Patients

The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic renal failure is a condition that causes irreversible damage to kidney functions and prevents the excretion of metabolic wastes through urine. In the treatment of the disease; renal replacement therapies and kidney transplant options are available. The most commonly used treatment in end-stage renal failure patients is hemodialysis. Hemodialysis is performed through catheters and fistula channels. Patients receiving hemodialysis treatment through fistula are connected to the dialysis device. For this procedure, an injection occurs 2 or 3 times a week. It is a distressing situation for patients that needle insertion is painful during the procedure and that conditions such as ecchymosis and hematoma frequently occur afterwards. In this study, cold application was planned in a pre-test post-test design to evaluate pain, ecchymosis, hematoma and patient satisfaction. Volunteer participants who receive hemodialysis treatment through fistula will receive an ice massage for an average of 3-5 minutes on the fistula area where the needle will be inserted before the procedure.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey
        • Ercan Bakır
      • Erzurum, Yakutiye, Turkey, 25010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Conscious and oriented
  • Communicable,
  • Those who are 18 years or older,
  • Hemodialysis treatment is applied via arteriovenous fistula,
  • There are no signs of infection such as redness, swelling, or open wound in the area where the procedure will be performed,
  • Patient: International Normalized Ratio: 2-3, Activated Partial Thromboplastin Time: 27-45 sec. Prothrombin Time: 11-16 sec. Thrombocyte: 125-350 m3
  • Can tolerate the application,
  • 10 minutes before starting Hemodialysis treatment. vissual analog scale pain score was evaluated beforehand and vissual analog scale was ≥4.
  • Patients who agree to participate in the study verbally and in writing will be included in the research.

Exclusion Criteria:

  • Unconscious,
  • Unable to communicate,
  • Those who are under 18 years of age,
  • Hemodialysis treatment is not applied via arteriovenous fistula,
  • If there is any sign of infection such as redness, swelling, open wound in the area where cannulation will be performed,
  • 10 minutes before starting hemodialysis treatment. vissual analog scale pain score was evaluated beforehand and vissual analog scale ≤ 4
  • Using any painkillers before the procedure on the same day,
  • Patient: International Normalized Ratio: 2-3, Activated Partial Thromboplastin Time: 27-45 sec. Prothrombin Time: 11-16 sec. Thrombocyte: above 125-350 m3, prone to bleeding,
  • Patients who cannot tolerate the application or do not want to participate in the study voluntarily will not be included in the research.

Exclusion Criteria:

Patients who cannot tolerate ice massage during the procedure will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ice massage group
Measurement surveys will be applied to obtain pre-test data from hemodialysis patients who meet the research criteria. After the preliminary test data are obtained, ice cubes prepared by the researchers before the needle insertion into the arteriovenous fistula for the hemodialysis procedure will be wrapped in a thin sponge and an ice massage will be applied to the needle insertion area of the patient in a direction that will not disrupt the circulation. This process will take approximately 3-5 minutes or the massage will be terminated when the patient feels drowsiness. In the next stage, the patient will undergo needle intervention for hemodialysis. At the end of this stage, the patient's pain will be evaluated. Patients will be re-evaluated at 24, 48 and 72 hours for ecchymosis and hematoma and relevant measurements will be provided.
Other: ice massage group
Measurement surveys will be applied to obtain pre-test data from hemodialysis patients who meet the research criteria. After the preliminary test data are obtained, ice cubes prepared by the researchers before the needle insertion into the arteriovenous fistula for the hemodialysis procedure will be wrapped in a thin sponge and an ice massage will be applied to the needle insertion area of the patient in a direction that will not disrupt the circulation. This process will take approximately 3-5 minutes or the massage will be terminated when the patient feels drowsiness. In the next stage, the patient will undergo needle intervention for hemodialysis. At the end of this stage, the patient's pain will be evaluated. Patients will be re-evaluated at 24, 48 and 72 hours for ecchymosis and hematoma and relevant measurements will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 3 days
Vissual analog scale: The scale is rated between 0 points and 10 points. 0 indicates that the patient has no pain, and 10 indicates that the patient has unbearable pain. Patients report their pain status on a scale of 0 to 10 points.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ecchymosis degree
Time Frame: 3 days
The area of the ecchymosis will be calculated in square millimeters with polyethylene millimetric plastic film (opsite flexigrid).
3 days
Hematoma degree
Time Frame: 3 days
The area of the hematoma will be calculated in square millimeters with polyethylene millimetric plastic film (opsite flexigrid).
3 days
Patient satisfaction score
Time Frame: 3 days
Numerical Satisfaction Scale: The scale is rated between 0 points and 10 points. 0 indicates that the patient is very dissatisfied, and 10 indicates that the patient is very satisfied. Patients report their satisfaction between 0 and 10 points.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzurum Technical University

Investigators

  • Study Director: Ercan Bakır, PhD, erzurum tecnical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • avf ice massage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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