Chronic Pain Clinical Trial
Official title:
Pain Monitor: a Randomized Controlled Trial to Test the Efficacy of a Pain App in the Treatment of Chronic Pain
Verified date | May 2018 |
Source | Universitat Jaume I |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present investigation aims at exploring the effect of including a pain app called Pain
Monitor for chronic pain patients' daily monitoring. Three conditions will be set:
1. usual treatment (waiting list)
2. usual treatment + app (without alarms)
3. usual treatment + app (with alarms)
Status | Completed |
Enrollment | 150 |
Est. completion date | April 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The patient is over 18 years of age - The patient has a mobile phone with Android operating system - The patient has the physical ability to use the application - The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult - The patient voluntarily wants to participate and signs the informed consent Exclusion Criteria: - The patient is under 18 years - The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons) - The patient does not have the physical capacity to use the application - The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language - The patient does not want to participate |
Country | Name | City | State |
---|---|---|---|
Spain | Vall d'Hebron Hospital | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Jaume I |
Spain,
Rosser BA, Eccleston C. Smartphone applications for pain management. J Telemed Telecare. 2011;17(6):308-12. doi: 10.1258/jtt.2011.101102. Epub 2011 Aug 15. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain intensity | A numerical rating scale (0-10 range) will be used. | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Primary | Change in side effects | A list of the most frequent side effects of pain medication was created | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Primary | Change in pain intensity | A numerical rating scale (0-10 range) will be used. | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Primary | Change in side effects | A list of the most frequent side effects of pain medication was created | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in mood | Questionnaire on mood validated against the Profile of Mood States | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in mood | Questionnaire on mood validated against the Profile of Mood States | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in rescue medication use | Amount of rescue medication will be assessed | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in rescue medication use | Amount of rescue medication will be assessed | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in pain interference | Interference of pain with patient's life | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in pain interference | Interference of pain with patient's life | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in general health | A general health item was validated against the phsyical health scale of the Short Form 12 | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in general health | A general health item was validated against the phsyical health scale of the Short Form 12 | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in fear of pain | 2 items validated against the Fear Avoidance Beliefs Scale | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in fear of pain | 2 items validated against the Fear Avoidance Beliefs Scale | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in pain acceptance | 2 items validated against the Chronic Pain Acceptance Questionnaire | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in pain acceptance | 2 items validated against the Chronic Pain Acceptance Questionnaire | Twice (first day of study and 30 days after, at the end of study) in the TAU condition | |
Secondary | Change in pain catastrophizing | 3 items validated against the Pain Catastrophizing Scale | Dialy during 30 days (app condition) in the app condition (with and without alarm) | |
Secondary | Change in pain catastrophizing | 3 items validated against the Pain Catastrophizing Scale | Twice (first day of study and 30 days after, at the end of study) in the TAU condition |
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