Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy

April 10, 2024 updated by: Zohour Ibrahim Mahmoud Rashwan, Alexandria University

Empowering Mind-Body Wellness: Effect of Bundling Seated Exercises and Psychoeducational Rehabilitation Using the Teach-Back Approach on Fatigue and Coping of Women Postmastectomy

This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.

Hypotheses for research:

  1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
  2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions.

Researchers prepared a health education unit and designed a booklet about seated exercises and psychological interventions. The developed program was applied to each patients using teach-back method.

Seated Exercises In the sitting position, women were instructed to perform different types of exercises. Researchers demonstrated each exercise and asked women to practice preoperatively to be ready for re-demonstrating them after surgery. Patients were asked to perform the exercise repeatedly until mastering the necessary skills.

Psychological Rehabilitation The participants received training about the implementation of four psychological interventions, namely mindfulness breathing, problem-solving training, cognitive reframing, and thought stopping.

Follow-up Women were instructed to practice each exercise ten times and repeat the whole activity five times per day. Women were followed up for two months to ensure their commitment to the program and provide the needed support.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 56321
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • Adult
  • Fully conscious
  • Having Breast Cancer
  • Planned for mastectomy

Exclusion Criteria:

- Hemodynamically unstable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seated Exercises
Women practiced seated exercises
Behavioral: Seated Exercises
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. women practiced seated exercises
Experimental: Psychoeducational Rehabilitation
Women received psychological rehabilitation
Behavioral: Psychoeducational Rehabilitation
Women received Psycho-educational Rehabilitation, including mindfulness breathing, problem-solving training, cognitive re-framing technique, and thought stopping.
Active Comparator: Routine Care
Women received routine health education in the unit
Behavioral: Routine Care
Women received routine health education in the unit, where nurses provided general instructions about the postoperative activities for women with breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Piper Fatigue Scale
Time Frame: one month
The scale was developed to measure the subjective dimension of fatigue. It include 22 items measuring four elements of subjective fatigue: behavioral/temporal (6 items), sensory (5 items), cognitive/mood (6 items), and affective/emotional meaning (5 items). Participants were asked to rate their level of fatigue on a scale ranging from 0 to 10. The total score ranges from 0 to 220; the higher the score, the higher the fatigue level
one month
Mini-Mental Adjustment to Cancer Scale
Time Frame: one month
This self-report survey created to gauge the cancer patients' ways to cope. It consists of 29 items rated on a four-point Likert scale ranging from 1 "Does not apply at all to me" to 4 "Totally applies to me"). It includes five subscales under two main categories: maladaptive coping, including helplessness/hopelessness (8 items), and anxious preoccupation (8 items). The higher the score, the higher the maladaptive coping. However, adaptive coping includes fighting spirit (4 items), fatalism (5 items), and cognitive avoidance (4 items) . In this category, high scores means increased the likelihood of adaptive coping skills.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Eman Taha, Professor, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

August 2, 2022

Study Completion (Actual)

August 12, 2022

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14012021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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