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

NCT ID: NCT06349395

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-07-29

Brief 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.

Detailed Description

This research aims to explore the effectiveness of mindfulness-based stress reduction (MBSR) training, delivered through an eight-session program prior to mastectomy, in alleviating postoperative pain-a critical challenge in breast cancer treatment. Recognizing the substantial impact of breast cancer on women's quality of life and the limitations of traditional pharmacological approaches to pain management, this study proposes a non-pharmacological intervention. By employing an experimental design, it investigates whether preoperative MBSR training can lead to a significant reduction in pain levels among patients undergoing mastectomy, compared to those who do not receive such training. The hypothesis suggests that mindfulness training, by fostering higher levels of mindfulness, may improve pain management, thereby enhancing patient outcomes and suggesting a potential shift towards incorporating holistic preparatory training in standard preoperative protocols. This approach aims to contribute to the evolving landscape of pain management strategies in breast cancer care, emphasizing patient-centered and integrative treatment modalities.

Conditions

Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

interventional

The study conducted an online eight-session mindfulness-based stress reduction (MBSR) program for its intervention group, with each session lasting about two hours. Daily exercise adherence was monitored via phone. The control group received no intervention but followed standard hospital protocols, with an offer for MBSR training post-study.

Group Type: EXPERIMENTAL

MBSR surgical nursing care

Intervention Type: OTHER

This study delivered an eight-session mindfulness-based stress reduction (MBSR) program online to its intervention group, each lasting about two hours, incorporating daily exercises monitored via phone. The evaluation of MBSR's effectiveness focused on postoperative pain at 6, 12, 18, and 24 hours after surgery and assessed fear of movement before starting arm exercises on the 5th day post-mastectomy. This approach provided a detailed examination of MBSR's role in pain and movement fear management, highlighting its potential as a preoperative care component for breast cancer patients.

controls(control group)

No intervention was provided to the control group; these participants were evaluated following the routine hospital treatment protocol. Participants who wished to receive MBSR training were offered the opportunity to do so after the completion of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MBSR surgical nursing care

This study delivered an eight-session mindfulness-based stress reduction (MBSR) program online to its intervention group, each lasting about two hours, incorporating daily exercises monitored via phone. The evaluation of MBSR's effectiveness focused on postoperative pain at 6, 12, 18, and 24 hours after surgery and assessed fear of movement before starting arm exercises on the 5th day post-mastectomy. This approach provided a detailed examination of MBSR's role in pain and movement fear management, highlighting its potential as a preoperative care component for breast cancer patients.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Nisantasi University

OTHER

Sponsor Role: lead

Responsible Party

Rabia Buse Ayyildiz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deniz Öztekin, Prof.

Role: STUDY_DIRECTOR

Dogus Universitesi

Locations

Istanbul University - Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Buse Ayyıldız, PhD(c)

Role: CONTACT

b_seayyildiz@hotmail.com

5533529695 ext. +90

Other Identifiers

NisantasiU

Identifier Type: -

Identifier Source: org_study_id