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

NCT05657262 | Completed

• 1 other identifier: 81829502.903/94
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Immunotherapy

Keywords

Immunotherapy; Z technique; comfort; pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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 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.

  three months

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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).

Other: Pre-post test; Behavioral: experimental group

Control group

OTHER

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

Other: Pre-post test

Interventions

Pre-post test OTHER

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

Control group; experimental group

experimental group BEHAVIORAL

The experiment group will be applied with the Z technique.

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Gönül GÖKÇAY

Kars, 36500, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 1753026 BACKGROUND

• 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.

  PMID: 7930099 BACKGROUND

• 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.

  PMID: 27753676 BACKGROUND

• 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.

  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.

  PMID: 35255535 RESULT

MeSH Terms

Conditions

Pain

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Gönül GÖKÇAY, Asist. Prof.

  Kafkas University-Kafkas University Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Zeynep Genç AKGÜN, RN

  Derince Training and Research Hospital

  STUDY CHAIR

• Ayşe ÇEVİRME, Prof. Dr.

  Sakarya University-Sakarya University Faculty of Health Sciences

  STUDY CHAIR

• Aylin Meşe TUNÇ, MsC

  Sakarya University-Sakarya University Faculty of Health Sciences

  STUDY CHAIR

• Nida EFETÜRK, Lecturer

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

  STUDY CHAIR

• Özge ERTÜRK, PhD

  Sakarya University-Sakarya University Faculty of Health Sciences

  STUDY CHAIR

• Seda GÖĞER, Phd

  Sakarya University-Sakarya University Health Care Services

  STUDY CHAIR

• Elif Seda UĞURLU, RN

  Sakarya University Training and Research Hospital

  STUDY CHAIR

• Hülya İncirkuş KÜÇÜK, RN

  Yalova State Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Prof.

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

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 20, 2022
• Study Start: October 3, 2022
• Primary Completion: December 30, 2022
• Study Completion: March 3, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)