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

NCT ID: NCT05657262

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-03-03

Brief Summary

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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

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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.

Conditions

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Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

experimental group: application of immunotherapy via Z technique control group: immunotherapy administration with standard procedure
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants were divided into groups using the "simple randomization method". Participants were not informed about which group they belonged to. Automated computer-based randomization resulted in the execution of the experiment with the timing scenario and the confidential assignment of participants to one of the 2 intervention arms. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or control condition. Additionally, researchers who code and analyze data will be blind to randomization and interference.

Study Groups

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experimental group

The experiment group will be applied with the Z technique. While applying the medicine with the Z technique, the tissue will be lifted with the thumb and forefinger of the left hand and pulled to the right, and the medicine will be slowly applied after the injector needle enters the tissue. When the application is finished, first the injector will be withdrawn, then the tissue will be released and the tissues will be restored (Altun, 2018).

Group Type EXPERIMENTAL

Pre-post test

Intervention Type OTHER

Personal Information Form, Vas Scale, Undesirable Symptoms Form and General Comfort Scale Questions will be asked to immunotherapy patients with this research.

experimental group

Intervention Type BEHAVIORAL

The experiment group will be applied with the Z technique.

Control group

In the control group, the vaccine will be administered slowly with the standard technique.

Group Type OTHER

Pre-post test

Intervention Type OTHER

Personal Information Form, Vas Scale, Undesirable Symptoms Form and General Comfort Scale Questions will be asked to immunotherapy patients with this research.

Interventions

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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.

Intervention Type OTHER

experimental group

The experiment group will be applied with the Z technique.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafkas University

OTHER

Sponsor Role lead

Responsible Party

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Gönül GÖKÇAY

Asist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gönül GÖKÇAY, Asist. Prof.

Role: PRINCIPAL_INVESTIGATOR

Kafkas University-Kafkas University Faculty of Health Sciences

Zeynep Genç AKGÜN, RN

Role: STUDY_CHAIR

Derince Training and Research Hospital

Ayşe ÇEVİRME, Prof. Dr.

Role: STUDY_CHAIR

Sakarya University-Sakarya University Faculty of Health Sciences

Aylin Meşe TUNÇ, MsC

Role: STUDY_CHAIR

Sakarya University-Sakarya University Faculty of Health Sciences

Nida EFETÜRK, Lecturer

Role: STUDY_CHAIR

Istanbul Okan University, Istanbul Okan University Vocational School of Health Services

Özge ERTÜRK, PhD

Role: STUDY_CHAIR

Sakarya University-Sakarya University Faculty of Health Sciences

Seda GÖĞER, Phd

Role: STUDY_CHAIR

Sakarya University-Sakarya University Health Care Services

Elif Seda UĞURLU, RN

Role: STUDY_CHAIR

Sakarya University Training and Research Hospital

Hülya İncirkuş KÜÇÜK, RN

Role: STUDY_CHAIR

Yalova State Hospital

Locations

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Gönül GÖKÇAY

Kars, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 1753026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7930099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27753676 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 35255535 (View on PubMed)

Other Identifiers

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81829502.903/94

Identifier Type: -

Identifier Source: org_study_id

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