Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione

NCT ID: NCT06224504

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-01

Brief Summary

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This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

Detailed Description

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To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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the intervention group

routine health education , psychological nursing, MBSR therapy , exercise therapy

Group Type EXPERIMENTAL

routine health education

Intervention Type BEHAVIORAL

guided the diet of patients, and introduced the knowledge of the disease in detail

psychological nursing

Intervention Type BEHAVIORAL

hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions

MBSR therapy

Intervention Type BEHAVIORAL

Conducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans

exercise therapy

Intervention Type BEHAVIORAL

Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day

the control group

routine health education , psychological nursing

Group Type ACTIVE_COMPARATOR

routine health education

Intervention Type BEHAVIORAL

guided the diet of patients, and introduced the knowledge of the disease in detail

psychological nursing

Intervention Type BEHAVIORAL

hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions

Interventions

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routine health education

guided the diet of patients, and introduced the knowledge of the disease in detail

Intervention Type BEHAVIORAL

psychological nursing

hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions

Intervention Type BEHAVIORAL

MBSR therapy

Conducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans

Intervention Type BEHAVIORAL

exercise therapy

Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with non-small cell lung cancer
* patients aged between 20 and 74 years, without gender limitation
* a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)
* a clinical prognosis of at least 6 months
* clear consciousness, good functional ability, and unrestricted language communication
* written informed consent provided by the patient

Exclusion Criteria

* patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening
* patients with a BSRS-5 assessment score \> 15 and suicidal ideation \> 2
* patients unable to accurately describe their symptoms
* patients with limited cooperation ability
* patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods
Minimum Eligible Age

44 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanxi Bethune Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wanling Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wanling Li

Role: PRINCIPAL_INVESTIGATOR

Shanxi Bethune Hospital

Locations

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Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer

Taiyuan, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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SBH-001

Identifier Type: -

Identifier Source: org_study_id

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