Clinical trial NCT05657262: Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas
Official title: The Effect of Z Technique Treatment on Comfort, Pain and Undesirable Symptoms in Allergy Patients Receiving Immunotherapy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunotherapy
Keywords: Immunotherapy
Z technique
comfort
pain
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: experimental group: application of immunotherapy via Z technique control group: immunotherapy administration with standard procedure
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1.VAS Scale:
timeFrame: three months
measure: 2.General Comfort Scale:
timeFrame: three months
measure: 3. Undesirable Symptoms Tracking Form:
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Gönül GÖKÇAY
Study officials:
affiliation: Kafkas University-Kafkas University Faculty of Health Sciences
name: Gönül GÖKÇAY, Asist. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Derince Training and Research Hospital
name: Zeynep Genç AKGÜN, RN
role: STUDY_CHAIR
affiliation: Sakarya University-Sakarya University Faculty of Health Sciences
name: Ayşe ÇEVİRME, Prof. Dr.
role: STUDY_CHAIR
affiliation: Sakarya University-Sakarya University Faculty of Health Sciences
name: Aylin Meşe TUNÇ, MsC
role: STUDY_CHAIR
affiliation: Istanbul Okan University, Istanbul Okan University Vocational School of Health Services
name: Nida EFETÜRK, Lecturer
role: STUDY_CHAIR
affiliation: Sakarya University-Sakarya University Faculty of Health Sciences
name: Özge ERTÜRK, PhD
role: STUDY_CHAIR
affiliation: Sakarya University-Sakarya University Health Care Services
name: Seda GÖĞER, Phd
role: STUDY_CHAIR
affiliation: Sakarya University Training and Research Hospital
name: Elif Seda UĞURLU, RN
role: STUDY_CHAIR
affiliation: Yalova State Hospital
name: Hülya İncirkuş KÜÇÜK, RN
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
citation: Arslan, Ş. & Çalışkaner, A. (2022) Subkutan Alerjen İmmünoterapisine Bağlı Lokal ve Sistemik Reaksiyonlar: Tek Merkezde 5 Yıllık Tecrübemiz. Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi Dergisi, 17 (1) , 1-8 . DOI: 10.17517/ksutfd.839958.
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.