An interventional study of Positive Self-Affirmation Audio with Calming Background Sounds in Breast Neoplasms, Mastectomy; Lymphedema and Pain, sponsored by Muş Alparslan University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Muş Alparslan University · Not applicable, Interventional, and Supportive care
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.
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.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
This study's planned enrollment of 42 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Muş Alparslan University is the lead sponsor of 62 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control arm will receive standard postoperative care according to hospital protocols. No additional behavioral or psychological intervention will be administered.
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
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.
Pain intensity
Measured using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain).
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)
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)
Time frame: T0 (preoperative baseline), T1 (post-op day 1), T2 (post-op day 3, before discharge), T3 (post-op day 10 follow-up).
Intervention adherence (daily listening frequency)
Number of completed listening sessions per day recorded on the "Listening Adherence Log"; minimum once daily recommended during hospitalization and until day 10 post-op.
Time frame: From T0 training through T3 (daily tracking until day 10 post-op).
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to confidentiality and ethical considerations.
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Oct 2026, 9 months later.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 9 months is below that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Muş Alparslan University