Self-Affirmation Intervention After Mastectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMuş Alparslan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosed psychiatric disorder
Hearing impairment that prevents listening to the audio intervention
Trial design
Design model
Parallel
Treatments tested in this trial
Positive Self-Affirmation Audio with Calming Background Sounds
BehavioralParticipants 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 groups
42 Participants
are divided into 2 treatment groupsGroup A: Control Group (Standard Care)No intervention 0 interventions
Group B: Intervention Group (Self-Affirmation Audio)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).Secondary outcomes
1
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).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: