UCLouvain/IONS
Brussels, 1200, Belgium
Location status: Recruiting
NCT Number: NCT07453524
The goal of this study is to ask chronic pain patients their preferences regarding which side effects of pain medications are least acceptable in relation to their pain relief benefits. This information may help in the selection of improved treatment options in the future.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brussels, 1200, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Online patient questionnaire that assesses multiple aspects such as current analgesic use, side effect burden, treatment satisfaction and patient preferences.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Using numeric rating scales from 0 to 10 (adaptation of the outcome prioritization tool) to assess patient perceived importance of analgesic effect relative to not having the following side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean the specific outcome is a higher priority for the participant.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Using numeric rating scales, from 0 to 10, to assess current burden of the following analgesic side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean being more affected by the side effects.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Numeric rating scale from 0 to 10, with higher scores meaning higher pain levels.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Numeric rating scale from 0 to 10, with higher scores meaning better sleep.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Patient treatment satisfaction will be assessed using 6 selected items from the Pain Treatment Satisfaction Scale (PTSS). The 6 items using 5-point Likert scales assess satisfaction of the time that it takes their pain medication to work, level or amount of pain relief, duration of pain relief, overall satisfaction, and to what extend the level of pain relief meet their expectations.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Patient characteristics including demographics and which pain type/diagnosis and medications and dose are used including alternative/supplementary treatments.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Single-item measure, on a scale from 1 to 10, that assesses a person's perceived rank relative to others with a higher score meaning a higher rank.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
Assessing global quality of life through a Numerical Rating Scale on a scale from 0 to 100 that includes 11 descriptive markers where a higher scores means a better QOL.
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
The PHQ-4 uses a 4-point Likert scale (Not at all, Several days, More than half the days, Nearly every day).
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
The COMM-9 uses a 5-point Likert scale (Never, Seldom, Sometimes, Often, Very often).
Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).
The PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a uses a 5-point Likert scale (Never, Rarely (Once), Sometimes (Two or three times), Often (About once a day), Very often (Several times a day)).
Université Catholique de Louvain
Other
Assessing Chronic Pain Patient Preferences Regarding the Analgesic Effect Relative to the Side Effects of Analgesic Drugs
Acronym: patientPREF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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