Self-Affirmation Intervention After Mastectomy

Muş Alparslan University

Status: Not yet enrolling

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

Treatments: Behavioral: Positive Self-Affirmation Audio with Calming Background Sounds

Study type: Interventional

Funder types: Other

Identifiers

NCT07355244

222391

Details and patient eligibility

About

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.

Full description

This randomized controlled trial is designed to evaluate the effect of a structured self-affirmation intervention on pain, depression, anxiety, and stress levels in patients undergoing mastectomy. Breast cancer is the most commonly diagnosed cancer among women worldwide, and mastectomy, a standard surgical treatment, often results in significant physical and psychosocial consequences. The loss of a breast, perceived as a symbolic part of femininity, can severely impact body image and self-esteem, leading to psychological distress symptoms such as depression, anxiety, and stress, as well as chronic pain. These adverse effects not only reduce quality of life but also negatively influence treatment adherence and long-term survival.

In this study, participants in the intervention group will listen to an audio recording containing positive self-affirmation statements accompanied by soothing background sounds such as birds chirping and flowing water. The recording, prepared by a certified practitioner, lasts approximately 5 minutes and 40 seconds. Patients will be instructed to listen to the recording at least once daily, with encouragement to listen more frequently if desired. The control group will receive standard care without any additional intervention. Primary outcomes will be assessed using the Visual Analog Scale (VAS) for pain and the Depression Anxiety Stress Scale (DASS-21) for psychological distress. The ultimate goal of this trial is to develop an evidence-based nursing and psychosocial support protocol that can be integrated into postoperative care to reduce psychosocial burden and improve well-being in mastectomy patients.

Enrollment: 42 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Control Group (Standard Care)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Positive Self-Affirmation Audio with Calming Background Sounds