The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal

NCT ID: NCT05214703

Last Updated: 2022-01-31

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-09-01

Brief Summary

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This study was conducted as a quasi-experimental study to examine the effect of cold therapy on pain and anxiety during venous port catheter removal.

Detailed Description

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Pain and anxiety experienced during diagnosis and treatment in cancer patients affect the physical, psychological, and interpersonal well-being of individuals and affect their lives in all aspects. Nurses play a very important role in pain control. Pain control is very important in terms of ensuring the comfort of patients and increasing their quality of life. In order to provide this control; nurses can use non-pharmacological treatment methods that they can apply independently in pain management. Patients experience procedural pain during insertion and removal of an implantable port catheter, which is one of the painful invasive procedures that are placed under the skin with a small incision, and insertion of a needle into the port catheter. When the literature is examined, it is seen that there are a limited number of studies in which non-pharmacological methods are used in the control of pain and anxiety related to the implantable venous port catheter procedure, and in these studies, distraction, music therapy, and inhaler aromatherapy. However, no study was found in which cold application was used to reduce the pain and anxiety caused by the removal of the port catheter in cancer patients. Therefore, the aim of the study is to evaluate the effectiveness of cold application on procedural pain and anxiety associated with port catheter removal, which is frequently used in the treatment of cancer patients. Cold therapy as an independent nursing intervention in reducing anxiety and pain management during port catheter removal in cancer/oncology patients; can be transferred to clinical practice by oncology nurses, improving the quality of nursing care, ensuring patient safety, and increasing patient satisfaction. In addition, the results of the research may contribute to the literature in terms of increasing evidence-based information on the use of the cold application in procedural pain and anxiety control in cancer patients.

Conditions

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Pain Anxiety

Keywords

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Cancer Venous Port Catheter Cold Therapy Pain Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment a clinical trial with experimental and control groups with
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cold therapy

Pain scores were measured with a visual analog scale (VAS) before the port catheter was removed from the patients in the experimental group. Before the port catheters were removed, cold application with an ice pack was applied to the patients whose first visual analog scale measurement was made by the researchers. The cold application was terminated an average of 15 minutes after the body temperature decreased by 1 °C.

Group Type EXPERIMENTAL

cold therapy application

Intervention Type OTHER

cold therapy

no intervention

The patients in the control group did not receive any intervention before and after port catheter removal.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cold therapy application

cold therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of cancer disease
* 18 years and over
* no analgesic medication before three hours before the catheter removal procedure
* conscious and cooperative
* no communication problems
* no visual no vision problems
* with stable vital signs
* without a diagnosis of anxiety disorder
* volunteer participation

Exclusion Criteria

* Body mass index less than 18.5
* receiving Oxaliplatin infusions before venous port catheter removal
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuksek Ihtisas University

OTHER

Sponsor Role lead

Responsible Party

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Arzu Bahar

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arzu bahar, PhD

Role: PRINCIPAL_INVESTIGATOR

Yuksek Ihtisas University

Locations

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Arzu Bahar

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bahar A, Aktas D, Sonmez M. Effects of Cold Therapy on Pain and Anxiety During Needle Removal From Implanted Ports. J Infus Nurs. 2023 Jan-Feb 01;46(1):36-42. doi: 10.1097/NAN.0000000000000495.

Reference Type DERIVED
PMID: 36571826 (View on PubMed)

Other Identifiers

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YuksekIU-ABAHAR-002

Identifier Type: -

Identifier Source: org_study_id