Clinical trial NCT06332118: The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction
Official title: The Effect of Ice Massage Applied Before Arteriovenous Fistula Cannulation Procedure on Pain, Ecchymosis, Hematoma and Patient Satisfaction in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis Complication
Keywords: Hemodialysis
ice massage
pain
hematoma
ecchymosis
patient satisfaction
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The research is quasi-experimental and relationship-seeking in a pretest-posttest format.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: 3 days
Secondary outcomes:
measure: Ecchymosis degree
timeFrame: 3 days
measure: Hematoma degree
timeFrame: 3 days
measure: Patient satisfaction score
timeFrame: 3 days
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ercan Bakır
state: Yakutiye
city: Erzurum
country: Turkey
facility: Ercan Bakır
state: Yakutiye
Study officials:
affiliation: erzurum tecnical university
name: Ercan Bakır, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.