Self-Affirmation Intervention After Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive Self-Affirmation Audio with Calming Background Sounds.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Mastectomy; Lymphedema, Pain, Depression. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Self-Affirmation Skills on Pain, Depression, Anxiety, and Stress in Patients Undergoing Mastectomy: A Randomized Controlled Trial
Overview
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.
Detailed 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.
Interventions
- Behavioral Positive Self-Affirmation Audio with Calming Background Sounds
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 des
Primary outcome measures
- Pain intensity [Time frame: 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) [Time frame: T0 (preoperative baseline), T1 (post-op day 1), T2 (post-op day 3, before discharge), T3 (post-op day 10 follow-up).]
Secondary outcome measures (1)
- Intervention adherence (daily listening frequency) [Time frame: From T0 training through T3 (daily tracking until day 10 post-op).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07355244 · 222391