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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05657262
Enrollment
60
Registered
2022-12-20
Start date
2022-10-03
Completion date
2023-03-03
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunotherapy

Keywords

Immunotherapy, Z technique, comfort, pain

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.

Interventions

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

BEHAVIORALexperimental group

The experiment group will be applied with the Z technique.

Sponsors

Kafkas University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1.VAS Scale:three monthsIt 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.
2.General Comfort Scale:three monthsComfort Theory was developed by Katharina Kolcaba in 1990. The sub-dimensions of the General Comfort Scale, which was validated and reliable in Turkish by Çıtlık Sarıtaş 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.
3. Undesirable Symptoms Tracking Form:three monthsIt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026