Effect of a Confidence-Building and Diaphragmatic Breathing-Assisted Graded Exposure on Kinesiophobia and Anxiety During First Mobilization Among Women After Cesarean Section

November 9, 2026 updated by: Ghadeer Fadhel Abbas

This quasi-experimental study will evaluate whether a program combining confidence building, diaphragmatic breathing (slow, deep belly breathing), and gradual exposure to movement can reduce fear of movement and anxiety during first mobilization after cesarean section.

The study will include two groups without random assignment. The intervention group will receive the combined program in addition to routine hospital care. The control group will receive routine hospital care only. Fear of movement and anxiety will be assessed before and after the intervention period in both groups. Changes will be compared between the groups to evaluate the effects of the program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:Women aged 18 years or older who have undergone cesarean section.

2. Women who are medically stable and approved by the responsible healthcare team for first mobilization.

3. Women who have not yet started their first out-of-bed mobilization at the time of baseline assessment.

4. Women who are able to understand the intervention instructions, communicate with the researcher, and complete the study assessment tools.

5. Women who are willing to participate and provide written informed consent.

Exclusion Criteria : Medical instability or a clinical contraindication to first mobilization.

7. Severe postoperative complications that prevent safe mobilization. 8. Neurological or musculoskeletal disorders that substantially impair the ability to stand or walk safely.

9. Cognitive or communication difficulties that prevent understanding the intervention or valid completion of the study assessment tools.

10. A severe psychiatric condition that substantially interferes with informed consent, participation in the intervention, or valid completion of the study assessments, as determined according to the approved study protocol.

-

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Confidence-Building and Breathing-Assisted Graded Exposure Group
Behavioral: Confidence Building and Diaphragmatic Breathing -Assisted Graded Exposure

The researcher will deliver the program in addition to routine hospital care after the clinical team confirms that the woman is medically stable and cleared for first mobilization after cesarean section.

Confidence building will include supportive discussion (approximately 5 minutes) to identify concerns, explain the movement sequence, and provide realistic reassurance and encouragement. Guided mental rehearsal (approximately 10 minutes) will help the woman mentally prepare for sitting, standing, and walking. This will be followed by 3 minutes of slow, comfortable diaphragmatic breathing without straining the surgical area.

Graded exposure-assisted mobilization will progress through five levels: in-bed position adjustment, upright sitting, sitting at the bedside, supported standing, and short assisted walking. Each level will be attempted according to clinical stability and tolerance, with positive feedback after successful completion.
No Intervention: Routine Care Control Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia (TSK-17)
Time Frame: Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups.

kinesiophobia will be assessed in both groups using the 17-item Tampa Scale for Kinesiophobia (TSK-17). Total scores range from 17 to 68, with higher scores indicating greater fear of movement. Changes from baseline to the post-intervention assessment will be compared between the intervention and control groups.
Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Anxiety Measured by the Visual Analogue Scale for Anxiety (VAS-A)
Time Frame: Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups

Anxiety will be assessed in both groups using a 100-mm Visual Analogue Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 100 (worst imaginable anxiety). Higher scores indicate greater anxiety. Changes from baseline to the post-intervention assessment will be compared between the intervention and control groups.
Baseline before the intervention and first mobilization, and immediately after completion of first mobilization; the same assessment timing will apply to both groups

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ghadeer Fadhel Abbas

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

  • Bandura, A. (1997). Self-efficacy: The exercise of control. W. H. Freeman. Gonella, S., Delfino, C., Rolfo, M., Rizzo, A., Esposito, V., Berchialla, P., & Campagna, S. (2021). Effects of a video-based preoperative educational intervention plus nurse-led reinforcement discussion on knowledge, self-efficacy, and resilience in patients undergoing major surgery. Clinical Nursing Research, 30(6), 753-761. https://doi.org/10.1177/1054773820986916 Peng, J., Luo, Y., Feng, L., Xiao, J., Feng, F., Zheng, Y., Bao, L., Yang, S., & Wu, X. (2025). Targeting kinesiophobia after thoracic surgery with an integrated protection motivation and exposure intervention: A randomized controlled trial. Journal of Pain Research, 18, 6911-6920. https://doi.org/10.2147/JPR.S544205 Prokopowicz, A., & Byrka, K. (2021). Effectiveness of mental simulations on the early mobilization of patients after cesarean section: A randomized controlled trial. Scientific Reports, 11, 22634. https://doi.org/10.1038/s41598-021-02036-1 Rittharomya, J., Krua-aum, P., & Aree-Ue, S. (2025). Effectiveness of a rehabilitation self-efficacy program on postoperative outcomes in older adults with hip fracture: A randomized controlled trial. Pacific Rim International Journal of Nursing Research, 29(1), 91-107. https://doi.org/10.60099/prijnr.2025.269063 Watson, G. M., Sutherland, J., Lacey, C., & Bridgman, P. G. (2022). A randomised crossover trial of QT response to hyperventilation-induced anxiety and diaphragmatic breathing in patients with stress cardiomyopathy and in control patients. PLoS ONE, 17(3), e0265607. https://doi.org/10.1371/journal.pone.0265607

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS -CBDB -GE -KA-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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