Creation and Validation of a Questionnaire Evaluating Diastasis Recti (QUEDIA)
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|ClinicalTrials.gov Identifier: NCT04158180|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Introduction Abdominal diastasis 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 abdominal diastasis 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 abdominal diastasis 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 abdominal diastasis. These consequences should include relevant parameters such as quality of life, perception of body image and secondary functional limitations.
The objective of this study is the creation and validation of a specific questionnaire to evaluate the signs and symptoms of diastasis of the rectus abdominis.
Material and methods A) Creation of the questionnaire
- Literature review
- Online survey
- Expert panel
- Pilot questionnaire test
B) Validation of the questionnaire The psychometric properties of the questionnaire will be evaluated in a sample of patients with abdominal diastasis. The sample will be composed of a group of women who present a separation of the rectus abdominis that come to the consultation of a specialized professional
|Condition or disease||Intervention/treatment|
|Diastasis Recti and Weakness of the Linea Alba Diastasis Recti||Diagnostic Test: Questionnaire|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||125 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Creation and Validation of a Questionnaire on Diastasis Recti Signs and Symptoms|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
- Diagnostic Test: Questionnaire
A battery of questionnaires will be propose to the participants
- Inter recti distance [ Time Frame: 1 week ]Caliper
- Quality of life (QOL) [ Time Frame: 1 week ]Questionnaire
- Body image [ Time Frame: 1 week ]Questionnaire
- Disability [ Time Frame: 1 week ]Questionnaire
- Abdominal pain [ Time Frame: 1 week ]Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158180
|Contact: Montserrat Rejano Campo, MScemail@example.com|