The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer

NCT06460974 | Not Yet Recruiting

• 1 other identifier: MU-HF-BVD-02
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.

Conditions

Patients With Breast Cancer

Keywords

Anxiety; Comfort; Breast Cancer; Stress; Stress Ball

Outcome Measures

Primary Outcomes (3)

• Distress Thermometer

  Distress level is determined by a visual analog scale ranging from "0-10". Patients express the psychological distress they feel with the numbers on the thermometer; "0 points" means that the patient does not experience any distress, and "10 points" means that the patient experiences the highest level of distress

  6 months

• State-Trait Anxiety Inventory

  It evaluates the state of anxiety felt by the individual due to the stressful situation he is in. The first 20 items, consisting of short statements, measure the individual's state anxiety level.

  6 months

• General Comfort Scale

  The scale contains a total of 48 items in a four-point Likert type and consists of four sub-dimensions (physical, psycho-spiritual, environmental, and socio-cultural sub-dimensions).

  6 months

Study Arms (2)

stress ball group

EXPERIMENTAL

A stress ball was applied to the patients in the stress ball group during chemotherapy treatment

Other: stress ball

Control group

NO INTERVENTION

Standard care without any additional application

Interventions

stress ball OTHER

A stress ball was applied to the patients in the during chemotherapy treatment.

stress ball group

Eligibility Criteria

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

You may qualify if:

• who is literate in Turkish,
• who was diagnosed with stage 1, 2 and 3 breast cancer
• who had the second cure or above chemotherapy receiving treatment
• over 18 years of age
• female
• platelet level \>50,000 mm3
• not having any physical problems squeezing a stress ball

You may not qualify if:

• those who did not agree to participate in the study
• those who received chemotherapy for the first time,
• those who had any physical disability to squeeze a stress ball
• Any receiving intravenous treatment from both arms,
• having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
• having any psychiatric disease,

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Birgül VURAL DOĞRU

  Mersin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgül VURAL DOĞRU

CONTACT

03243610001; bvuraldogru@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)