NCT07355244|Not Yet Recruiting
Self-Affirmation Intervention After Mastectomy
The Effect of Self-Affirmation Skills on Pain, Depression, Anxiety, and Stress in Patients Undergoing Mastectomy: A Randomized Controlled Trial
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The Effect of Self-Affirmation Skills on Pain, Depression, Anxiety, and Stress in Patients Undergoing Mastectomy: A Randomized Controlled Trial
Sponsor study identifier
interventional
42
0 countries
N/A
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 12, 2026
Actual (reported)January 21, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Intervention adherence (daily listening frequency)
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
January 12, 2026
First Posted
January 21, 2026
The PredictPlusPrevent Study
From T0 training through T3 (daily tracking until day 10 post-op).
Contact the study team to confirm eligibility.
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 21, 2026
Record last verified: 2026-01
Individual participant data will not be shared due to confidentiality and ethical considerations.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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