Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-Ambulatory Hip Pain questionnaire: a new questionnaire for care givers to identify hip pain in pediatric patients with quadriplegia

Study summary

The goal of this clinical trial is twofold:

1. to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently
2. to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia

Researchers will :

1. involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire
2. assess construct validity and reliability of the questionnaire submitting it to 100 care givers of pediatric patients with quadriplegia, and comparing results with the Revised Face Legs Activity Cry and Consolability (r-FLACC) Scale assessed by the physiatrist during the visit

Participants will:

1. as experts, firstly answer open questions on this topic, secondly evaluate each item of the new questionnaire by means of a 5-point Liekert scale
2. as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit

Eligibility

Primary outcome measure(s)

• Content validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq) — The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
  The questionnaire developed by means of the Delphi Method will be submitted to a group of 8-10 experts. They will evaluate each item and attribute one of the following judgments "essential", "usefull but not essential" or "unnecessary". The content validity ratio (CVR) for each item and the overall content validity index (CVI) will be calculated. The CVI is expected to be \> 0.75 for eight-expert group or \> 0.62 for 10-expert group. In case of lower values the items with the lowest CVR values will require to be revised, considering the experts' comments. The minimum and maximum values of the NAHPq are to be defined during the development Delphi phase; higher values will represent higher pain.
• Internal reliability of the Non-Ambulatory Hip Pain questionnaire (NAHPq) — The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
  After validity assessment, the questionnaire will be submitted to 100 caregivers of quadriplegic non-communicative patients aged 1-20 years. The Pearson's coefficient will be used to assess the inter-item correlation and the item-to-total correlation. The Cronbach's alpha will be calculated to measure the internal consistency.

Trial sites (2)

More Azienda USL Reggio Emilia - IRCCS trials in Italy