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CompletedNCT03436888PELVICUpdated Nov 28, 2023

Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

An observational study in Pelvic Girdle Pain, Pregnancy Related and Postpartum Period, sponsored by University Hospital, Caen. Completed at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
134
Ages
18 Years and older
Sex
Female
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Study summary

The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.

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Conditions studied

  • Pelvic Girdle Pain
  • Pregnancy Related
  • Postpartum Period

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult pregnant or in postpartum period females suffering of pelvic girdle pain. The symptoms must occur during pregnancy or within 3 weeks after childbirth.

Inclusion criteria

  • Women from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system.

Exclusion criteria

Exclusion Criteria:

  • Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
134 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Disability

    Disability will be measured using Pelvic Girdle Questionnaire

    Time frame: up to ten days

Secondary outcomes

  1. Disability: Oswestry disability index

    Disability will be measured using Oswestry disability index

    Time frame: 1 day (First appointment)

  2. fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire

    Fear Avoidance Beliefs will be measured using Fear Avoidance Beliefs Questionnaire

    Time frame: 1 day (First appointment)

  3. Pain Catastrophizing: Pain catastrophizing scale

    Pain catastrophizing will be measured using pain catastrophizing scale

    Time frame: 1 day (First appointment)

  4. health-related quality of life: SF 8 scale

    Health-related quality of life will be measured using SF 8 scale

    Time frame: 1 day (First appointment)

  5. Pain: Visual Analogue Pain Rating Scale

    Pain will be measured using Visual Analogue Pain Rating Scale

    Time frame: 1 day (First appointment)

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Study locations

2 sites
  • Pôle de Santé de la Grâce de Dieu
    Caen, 14000, France
  • Caen University Hospital
    Caen, 14033, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03436888
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Mar 15, 2018
Primary completion
Aug 25, 2023
Completion
Aug 25, 2023
Last update
Nov 28, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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