Comparison the effectiveness of Cryotherapy, EMLA Cream, and Lidocaine Spray to Reduce Pain during Arteriovenous Fistula Puncture among clients undergoing hemodialysis

To compare the effectiveness of three pain reliving techniques (cryotherapy, EMLA cream, or lidocaine spray) to reduce pain during arteriovenous fistula puncture in clients undergoing hemodialysis

An experimental multi-center study design with three parallel groups, randomized trial, open-label (unblinded). The minimum sample size for each group will be 28 with a total of 112 subjects

Seven hemodialysis centers in seven hospitals (Al-Hussein Medical City, Imam Al-Hassan Al-Mujtaba Hospital, Hussein Teaching Hospital, Al-Karama, Al-Kadhumain Teaching, Al-Kindy Teaching Hospital, Baghdad Teaching Hospital) in four different cities across Iraq

The inclusion criteria for this study were; clients with more than 18 years old, being under hemodialysis at least for three months, conscious and alert, and be able to sign the written informed consent. Clients were excluded under the following criteria; cold intolerance, allergy from local anesthetics or topical medications, upper extremities paralysis, and pregnant or lactating females.

There will be three intervention groups; Ice pack, EMLA cream, and lidocaine. For ice pack group, 5 cubs of ice (4 × 2 × 2 cm) will placed in a plastic bag and covered with a layer of cotton cloth for five minutes on the site of arteriovenous fistula (AVF). For EMLA group, 1.5 g of EMLA cream will be applied to six cm2 on the area of AVF for 20 minutes before the AVF puncture. For lidocaine group, three sprinklings of lidocaine spray will be sprayed before the AVF puncture for five minutes. After the intervention for each group, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion by using Visual Analogue Scale.

Reduce pain during arteriovenous fistula puncture

A simple randomization sampling method will be used to assign the study sample in four groups: ice pack, EMLA cream, lidocaine spray, and a control group. Simple randomization is an appropriate method to be used in this clinical trial to increase the probability and reduce and bias. A sealed envelope contained four colors (red, blue, green, and yellow) will be given to each client to choose one color. The clients were allocated to groups based on their colors; red= control, blue= ice pack, green= EMLA cream, and yellow= lidocaine spray. Indeed, four groups will be allocated randomly.

The data will be the results of Visual Analogue Scale that measure clients' pain during AVF puncture in both control and interventions groups.

If the article is published in an open access journal, the data will be available after 6 months of publication. If the article is published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals.

With academic nurses and any researcher who is interested in the data

The data could be used after getting the authors' permission via email. Also, users need to acknowledge the owner.

Users can ask for the data and the permission via email. Dr. Al-Jubouri is the corresponding author. He will be in contact with whom ask for the data. His email is maaljubouri@conursing.uobaghdad.edu.iq Also, Dr. Al-Jubouri works at University of Baghdad/ College of Nursing. The address is Bab Al-Muadham, Baghdad, Iraq.

Users can ask for the data and the permission via email. Dr. Al-Jubouri is the corresponding author. He will be in contact with whom ask for the data. His email is maaljubouri@conursing.uobaghdad.edu.iq