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

NCT06332118 | Not Yet Recruiting

• 1 other identifier: avf ice massage
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemodialysis Complication

Keywords

Hemodialysis; ice massage; pain; hematoma; ecchymosis; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Pain score

  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 Outcomes (3)

• Ecchymosis degree

  3 days

• Hematoma degree

  3 days

• Patient satisfaction score

  3 days

Study Arms (1)

ice massage group

EXPERIMENTAL

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

Interventions

ice massage group OTHER

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.

ice massage group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Erzurum Technical University: lead

Study Sites (2)

Ercan Bakır

Erzurum, Yakutiye, 25010, Turkey (Türkiye)

Location

Ercan Bakır

Erzurum, Yakutiye, Turkey (Türkiye)

Location

Related Publications (5)

• Koushki B, Khajeh M, Bagheri H, Talebi SS, Ebrahimi H. Comparing the Effect of Local Application of Peppermint and Cold Compresses on the Severity of Pain from Venipuncture in Dialysis Patients: A Parallel Randomized Clinical Trial Study. Saudi J Kidney Dis Transpl. 2023 Jul 1;34(4):288-296. doi: 10.4103/1319-2442.395444. Epub 2024 Feb 12.

  PMID: 38345583 BACKGROUND

• Ghoreyshi Z, Amerian M, Amanpour F, Ebrahimi H. Evaluation and comparison of the effects of Xyla-P cream and cold compress on the pain caused by the cannulation of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl. 2018 Mar-Apr;29(2):369-375. doi: 10.4103/1319-2442.229265.

  PMID: 29657205 BACKGROUND

• Kesik G, Ozdemir L, Yildirim T, Jabrayilov J, Celiksoz G. Effects of warm or cold compresses applied to the legs during hemodialysis on cramps, fatigue, and patient comfort: A placebo-controlled randomized trial. Hemodial Int. 2023 Apr;27(2):117-125. doi: 10.1111/hdi.13070. Epub 2023 Feb 14.

  PMID: 36788410 BACKGROUND

• Dehghan M, Hosseini SJ, Shahrbabaki PM, Forouzi MA, Roy C. The Effect of Acupressure and Cryotherapy on the Pain of Patients on Hemodialysis During Arteriovenous Fistula Cannulation: A Randomized Crossover Clinical Trial. Nephrol Nurs J. 2023 Mar-Apr;50(2):131-139.

  PMID: 37074938 BACKGROUND

• Al Amer HS, Dator WL, Abunab HY, Mari M. Cryotherapy intervention in relieving arteriovenous fistula cannulation-related pain among hemodialysis patients at the King Khalid Hospital, Tabuk, Kingdom of Saudi Arabia. Saudi J Kidney Dis Transpl. 2017 Sep-Oct;28(5):1050-1056. doi: 10.4103/1319-2442.215141.

  PMID: 28937062 BACKGROUND

MeSH Terms

Conditions

Pain; Hematoma; Ecchymosis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Manifestations; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ercan Bakır, PhD

  erzurum tecnical university

  STUDY DIRECTOR

Central Study Contacts

Ercan Bakır, PhD

CONTACT

05444252111; ercan.bakir@erzurum.edu.tr

Ercan Bakır, PhD

CONTACT

05443047186; e.bakir02@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof

Model Details: The research is quasi-experimental and relationship-seeking in a pretest-posttest format.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 27, 2024
• Study Start: April 15, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)