Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas

Immunotherapy Clinical Trial

Official title:

The Effect of Z Technique Treatment on Comfort, Pain and Undesirable Symptoms in Allergy Patients Receiving Immunotherapy: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657262
• Other study ID #: 81829502.903/94
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: February 2024
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An allergy is an abnormal response of the immune system to a generally harmless antigen. Pollens in the air play an important role in the formation of respiratory allergies and can be a trigger for the development of allergies (Won, 2022). By providing relaxation by nurses and taking measures to ensure the continuity of relaxation; Maintaining the well-being of the individual, family or society is possible with the comfort theory (Kolcaba and Kolcaba, 1991; Kolcaba, 1994). Although subcutaneous immunotherapy is performed in the presence of specialist physicians and trained nurses, some local side effects may develop after injection. One of the local side effects is pain, swelling and redness at the injection site (Arslan and Caliskaner, 2022).

The aim of this study; The aim of this study is to determine the effect of the treatment with the Z technique on allergy patients receiving immunotherapy on comfort, pain and adverse symptoms using a randomized controlled experimental method.

The hypotheses of the study H0: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy has no effect on comfort levels, pain and adverse symptoms H1: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Comfort Levels H2: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Pain Levels H3: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Undesirable Symptoms

Description:

An allergy is an abnormal response of the immune system to a generally harmless antigen. Pollens in the air play an important role in the formation of respiratory allergies and can be a trigger for the development of allergies (Won, 2022). By providing relaxation by nurses and taking measures to ensure the continuity of relaxation; Maintaining the well-being of the individual, family or society is possible with the comfort theory (Kolcaba and Kolcaba, 1991; Kolcaba, 1994). Although subcutaneous immunotherapy is performed in the presence of specialist physicians and trained nurses, some local side effects may develop after injection. One of the local side effects is pain, swelling and redness at the injection site (Arslan and Caliskaner, 2022).

The aim of this study; The aim of this study is to determine the effect of the treatment with the Z technique on allergy patients receiving immunotherapy on comfort, pain and adverse symptoms using a randomized controlled experimental method.

The hypotheses of the study H0: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy has no effect on comfort levels, pain and adverse symptoms H1: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Comfort Levels H2: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Pain Levels H3: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Undesirable Symptoms The research is a pre-post-test two-group randomized controlled study in experimental design.

The research population consists of 104 patients who received allergy treatment in Kocaeli Derince Training and Research Hospital in the last year. In this study, "G. In the calculation made using the "Power-3.1.9.2" program and using a similar study at the sample level at 80% confidence level (yilmaz et al., 2016), a total of 60 individuals, 30 of which were experimental and 30 of which were control, was determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 3, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

To be receiving immunotherapy treatment at Kocaeli Derince Training and Research Hospital, be between the ages of 18-65, Volunteering to participate in the research,

Exclusion Criteria:

Not wanting to participate in the research voluntarily The state of moving the individual to a different country for any reason The end of the immunotherapy treatment period

Related Conditions & MeSH terms

• Immunotherapy

Intervention

Other:
• Pre-post test
Personal Information Form, Vas Scale, Undesirable Symptoms Form and General Comfort Scale Questions will be asked to immunotherapy patients with this research.

Behavioral:
• experimental group
The experiment group will be applied with the Z technique.

Locations

Country	Name	City	State
Turkey	Gönül GÖKÇAY	Kars

Sponsors (1)

Lead Sponsor	Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Arslan, S. & Çaliskaner, A. (2022) Subkutan Alerjen Immünoterapisine Bagli Lokal ve Sistemik Reaksiyonlar: Tek Merkezde 5 Yillik Tecrübemiz. Kahramanmaras Sütçü Imam Üniversitesi Tip Fakültesi Dergisi, 17 (1) , 1-8 . DOI: 10.17517/ksutfd.839958.

Kolcaba KY, Kolcaba RJ. An analysis of the concept of comfort. J Adv Nurs. 1991 Nov;16(11):1301-10. doi: 10.1111/j.1365-2648.1991.tb01558.x. — View Citation

Kolcaba KY. A theory of holistic comfort for nursing. J Adv Nurs. 1994 Jun;19(6):1178-84. doi: 10.1111/j.1365-2648.1994.tb01202.x. — View Citation

Oh JW. Pollen Allergy in a Changing Planetary Environment. Allergy Asthma Immunol Res. 2022 Mar;14(2):168-181. doi: 10.4168/aair.2022.14.2.168. — View Citation

Yilmaz D, Khorshid L, Dedeoglu Y. The Effect of the Z-Track Technique on Pain and Drug Leakage in Intramuscular Injections. Clin Nurse Spec. 2016 Nov/Dec;30(6):E7-E12. doi: 10.1097/NUR.0000000000000245. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.VAS Scale:	It is a scale numbered from 1 to 10 to measure the severity of pain that may occur after immunotherapy. Individuals rank 10 points for pain they feel most intensely and 1 point for pain they feel least severe.	three months
Primary	2.General Comfort Scale:	Comfort Theory was developed by Katharina Kolcaba in 1990. The sub-dimensions of the General Comfort Scale, which was validated and reliable in Turkish by Çitlik Saritas et al. in 2018, were defined as relief (9 items), relaxation (9 items), and overcoming problems (10 items). The lowest possible value, 1, indicates low comfort, and the highest value, 6, indicates high comfort.	three months
Primary	3. Undesirable Symptoms Tracking Form:	It is a form we developed to evaluate swelling, redness and leakage of the drug after 1 hour and 1 day after immunotherapy. Undesirable Symptoms Follow-up Form will be prepared and applied to the individuals participating in the study.	three months