UnknownNot Applicable

The Effect of Mindfulness-Based Stress Reduction Training Before Mastectomy on Postoperative Pain in Early Period

Turkey (Türkiye)40 participantsStarted 2023-05-01

Plain-language summary

This research aims to investigate the effect of mindfulness-based stress reduction training given before mastectomy on postoperative early period pain and the fear of movement caused by pain. According to the World Health Organization, 18.1 million new cancer diagnoses are made each year, with breast cancer being the most common type among women, accounting for 24.2% of all cancers diagnosed. In Turkey, the incidence of breast cancer was determined as 22,345 in 2018. Breast cancer significantly affects women's quality and length of life. Surgical intervention is the most commonly chosen treatment method for cases of localized breast cancer. Pain and limited movement are among the most common problems encountered after surgery. Non-pharmacological methods have been shown to be effective in pain management, with the mindfulness-based stress reduction technique being one of these methods. This technique is described as an effective treatment for conditions such as pain, depression, and addiction, with high levels of mindfulness being associated with greater self-esteem, optimism, and empathy, whereas low levels of mindfulness are linked to depression, anxiety, chronic pain, and acute pain.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Verbally and in writing agreed to participate in the study after being informed about the research, Are aged 18 and over, Can read, write, and speak Turkish, understand the provided information, and have no issues with verbal communication, Do not have any physical issues that would prevent participation in mindfulness-based stress reduction training, Have not previously received mindfulness-based stress reduction training, Underwent surgery with general anesthesia, Had arterial blood pressure, pulse, oxygen saturation, and body temperature within normal limits during and after surgery, Received non-narcotic and consistent analgesic substances postoperatively for pain control, Were administered antibiotics postoperatively with the same active ingredient. Exclusion Criteria: * Patients without internet access, Those unable to use the application through which the training is provided or without someone to assist them, Individuals who cannot allocate regular time for the training, Patients with chronic pain during the preoperative period who are using analgesics for treatment, Patients with restricted movement activity before the surgery will not be included

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analog scale

Timeframe: after operation 6.hours, 12 hours, 18 hours, 24 hours

The Tampa Scale of Kinesiophobia

Timeframe: after operation before starting arm exercises (5th day)

Trial details

NCT IDNCT06349395

SponsorIstanbul Nisantasi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-29

Contact for this trial

Buse Ayyıldız, PhD(c)

5533529695 b_seayyildiz@hotmail.com

View on ClinicalTrials.gov More Pain Management trials