Creation and Validation of a Questionnaire Evaluating Diastasis Recti

NCT04158180 | Unknown

• 1 other identifier: QUEDIA
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction. Distasis rectus abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. Some authors describe a prevalence of 40% in women up to one year postpartum. Some studies suggest that the presence of DRA can be related to the appearance of low back, pelvic and abdominal pain and even urinary incontinence. These factors can significantly affect the quality of life of women with diastasis both socially, sexual and personal level. According to several studies, this pathology is related to higher rates of depression and an alteration in the self-perception of body image that makes these women to look to specialized medical care. At present, the quantitative evaluation of DRA is performed purely anatomically. This evaluation consists in measuring the separation between the two rectus abdominis. Currently there is no consensus as to the protocol that should be used for this measurement. So far, no instrument is able to quantitatively measure the consequences of DRA. The evaluation of symptoms and consequences should include relevant parameters such as quality of life, perception of body image and functional limitations. The objective of this study is the creation and validation of a specific questionnaire to evaluate the symptoms and consequences of DRA. Material and methods. A) Development of the questionnaire

1. 1.Literature review
2. 2.Online survey
3. 3.Expert panel
4. 4.Pilot test of the questionnaire

Conditions

Diastasis Recti and Weakness of the Linea Alba; Diastasis Recti

Outcome Measures

Primary Outcomes (1)

• Diastasis abdominal consequences

  Diastasis rectus abdominis consequences will be measured using the Diastasis rectus abdominis questionnaire

  7 to 10 days after initial assessment

Secondary Outcomes (7)

• Inter-recti distance

  Initial assessment

• Subjective well-being

  Initial assessment

• Gastrointestinal symptoms

  Initial assessment

• Functioning

  Initial assessment

• Body image

  Initial assessment

Interventions

Questionnaire DIAGNOSTIC_TEST

A battery of questionnaires will be propose to the participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with diastasis recti attending to a physiotherapist or midwive center will be proposed to participate in the study. A signed informed consent will be necessary to participate in this research.

You may qualify if:

• subjects with diastasis recti,
• adult,
• women.

You may not qualify if:

• cognitive disabilities that can difficult a good understanding of the questionnaire,
• lack of knowledge of Spanish language.
• ventral hernia.
• previous abdominal surgeries.

Sponsors & Collaborators

• University of Valencia: lead
• University Hospital, Caen: collaborator

Study Sites (2)

Haro&Campos Physiotherapy.

Plasencia, Cáceres, 10600, Spain

RECRUITING

Department of Physiotherapy. University of Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Montserrat Rejano Campo, PhD(c)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Montserrat Rejano Campo, PhD(c)

CONTACT

0033627083914; montserejano@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 8, 2019
• Study Start: September 27, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 15, 2023
• Last Updated: May 23, 2023

Record last verified: 2022-11

Locations

ES (2)