The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer

NCT06735456 | Completed

• 1 other identifier: SBU-FUT-03
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer receiving chemotherapy.

Conditions

Breast Cancer

Keywords

Breast cancer; Nursing; Mandala

Outcome Measures

Primary Outcomes (5)

• Physiological parameter 1

  Temperature

  2 hours (pre-test and post-test)

• Physiological parameter 2

  Pulse

  2 hours (pre-test and post-test)

• Physiological parameter 3

  Blood pressure

  2 hours (pre-test and post-test)

• Physiological parameter 4

  spO2

  2 hours (pre-test and post-test)

• Physiological parameter 5

  Respiratory rate

  2 hours (pre-test and post-test)

Secondary Outcomes (1)

• Beck Anxiety Scale

  2 hours (pre-test and post-test)

Study Arms (2)

Mandala Group

EXPERIMENTAL

The patient will undergo mandala painting during 1 session of chemotherapy.

Other: Mandala

Control Group

NO INTERVENTION

No application will be made to this group by the researcher.

Interventions

Mandala OTHER

The patient will undergo mandala painting during 1 session of chemotherapy.

Mandala Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since it is a study conducted on breast cancer women, it concerns the female gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with breast cancer,
• Being receiving adjuvant or neoadjuvant chemotherapy,
• Being over 18 years of age,
• Ability to communicate in Turkish,
• Not having a physical disability related to the upper extremities,
• Agreeing to participate in the study.

You may not qualify if:

• Advanced stage cancer patients,
• Having visual, hearing and speech disabilities,
• Individuals with mental and neuropsychiatric diseases will not be included in the sample.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Filiz Ünal Toprak

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Since the application will be performed by the researcher, patients will be blinded in this study. The statistician will be blinded in the evaluation of the data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: Two groups with a mandala group and control group

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 16, 2024
• Study Start: February 24, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)