Self-Affirmation Intervention After Mastectomy

NCT07355244 | Not Yet Recruiting

• 1 other identifier: 222391
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to evaluate the effect of a structured self-affirmation intervention on pain, depression, anxiety, and stress levels in patients undergoing mastectomy. The study will be conducted in two parallel groups, with the intervention group listening to an audio recording of positive self-affirmation statements. Primary outcomes will be assessed using the Visual Analog Scale and the Depression Anxiety Stress Scale (DASS-21). The goal is to provide evidence-based strategies to reduce psychosocial burden after mastectomy.

Conditions

Mastectomy; Lymphedema; Pain; Depression; Stress, Psychological; Breast Neoplasms

Keywords

Mastectomy; Breast Cancer; Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Measured using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain).

  Baseline (preoperative, T0), postoperative day 1 (T1), postoperative day 3 (T2, before discharge), and day 10 follow-up (T3).

• Depression, Anxiety, and Stress (DASS-21 subscales)

  Assessed using the DASS-21 (validated Turkish version), a 21-item instrument with three subscales (depression, anxiety, stress), Likert 0-3; reliability previously reported (Cronbach's α \~0.88 in this study)

  T0 (preoperative baseline), T1 (post-op day 1), T2 (post-op day 3, before discharge), T3 (post-op day 10 follow-up).

Secondary Outcomes (1)

• Intervention adherence (daily listening frequency)

  From T0 training through T3 (daily tracking until day 10 post-op).

Study Arms (2)

Control Group (Standard Care)

NO INTERVENTION

Participants in the control arm will receive standard postoperative care according to hospital protocols. No additional behavioral or psychological intervention will be administered.

Intervention Group (Self-Affirmation Audio)

EXPERIMENTAL

Participants in the intervention arm will receive a behavioral intervention consisting of an audio recording of positive self-affirmation statements accompanied by calming background sounds (birds chirping and flowing water). The recording lasts approximately 5 minutes and 40 seconds and will be delivered via an MP3 player and headphones. Patients will be instructed to listen to the recording at least once daily during the postoperative period, with encouragement to listen more frequently if desired.

Behavioral: Positive Self-Affirmation Audio with Calming Background Sounds

Interventions

Positive Self-Affirmation Audio with Calming Background Sounds BEHAVIORAL

Participants in the intervention arm will receive a behavioral intervention consisting of an audio recording of positive self-affirmation statements accompanied by calming background sounds (birds chirping and flowing water). The recording lasts approximately 5 minutes and 40 seconds and will be delivered via an MP3 player and headphones. Patients will be instructed to listen to the recording at least once daily during the postoperative period, with encouragement to listen more frequently if desired.

Intervention Group (Self-Affirmation Audio)

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Female patients who have undergone mastectomy surgery
• Able to speak and understand Turkish
• Provides informed consent and agrees to participate voluntarily

You may not qualify if:

• Diagnosed psychiatric disorder
• Hearing impairment that prevents listening to the audio intervention

Sponsors & Collaborators

• Muş Alparslan University: lead

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Pain; Depression; Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Ömer TAŞÇI, PhD

CONTACT

+90 541 276 2620; o.tasci@alparslan.edu.tr

Barış ÖZDERE, RN, MSc

CONTACT

+90 539 767 5964; b.ozdere6565@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label. Masking was not feasible due to the nature of the behavioral intervention (audio recording of self-affirmation statements). Both participants and investigators were aware of group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study uses a parallel assignment model with two arms: an intervention group and a control group. Participants will be randomly assigned to groups using block randomization via a computer-based system (randomizer.org). The intervention group will receive a structured self-affirmation audio recording with calming background sounds, while the control group will receive standard care without additional intervention. The study is open-label, as masking is not feasible due to the nature of the behavioral intervention.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share