CClinicalTrials.gg
CompletedNCT05149417Updated Aug 10, 2022

Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

An interventional study of SMS reminding and telemonitoring in Post-traumatic Pain, sponsored by University of Monastir. Completed at 2 sites in Tunisia. Open to participants aged 16 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by University of Monastir · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Aug 2020, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
1,350
Allocation
Randomized
Ages
16 Years to 90 Years
Sex
All
01

Study summary

The impact of telemonitoring on patients' adherence to post trauma pain treatment , their satisfaction and pain relief after discharge from the ED.

Read the detailed description

This is a prospective, multicenter, randomized trial . Participants are recruited from the emergency departement of Fattouma Bourguiba Monastir.

This study is a seven day three-arm parallel group trial . Participants inculded are aged more than 16 years old who presented to the ED for minor trauma and discharged with analgesic treatment. They are randomized to one of two trial TM intervention groups (SMS and TM) or usual care group (control) in a 1 :1 :1 allocation ratio.

For all inculded patients, demographic characteristics were collected as well as clinical examination findings. The interventional care provided at the ED was mentioned. At ED discharge the pain Visual Analogue Scale (VAS) was evaluated and the analgesic treatment prescribed was noted.

02

Conditions studied

  • Post-traumatic Pain

Keywords

  • Telemedecine
  • Adherence
  • post- traumatic pain
03

In context

Lead sponsor

University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age >16 years old with minor trauma and discharged with an analgesic treatment.
  • Included patients should have regular access to a mobile phone ,were able to interact with SMS or could do so with help of a relative.
  • Patients who accepted to participate to the study.
  • No contraindication to analgesic medication

Exclusion criteria

Exclusion Criteria:

  • Swallowing disorder or inability to swallow.
  • Unsuitable for follow-up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,350 participants (actual)

Study arms

  • Placebo comparator
    Standard group

    Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.

    Other: telemonitoring

  • Active comparator
    SMS group

    patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .

    Other: SMS reminding

  • Active comparator
    telemonitoring group

    Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.

    Other: telemonitoring

Interventions

  • OtherSMS reminding

    patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .

  • Othertelemonitoring

    Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.

06

What researchers measure

Primary outcomes

  1. Visual analog scale after 7 days of follow-up

    Patient's adherence to analgesics treatment which was assessed by calling patients or by sending SMS in day 2, day 4,and day 7 in SMS group and the telemonitoring group respectively.

    Time frame: at seven day after ED discharge .

Secondary outcomes

  1. Likert scale

    Patients' satisfaction which was assessed through likert scale. minimum=1(strongly disagree) , maximum=5 (strongly agree)

    Time frame: at seven day post ED discharge .

07

Study locations

2 sites
  • Fattouma Bourguiba Monastir University Hospital Center
    Monastir, 5000, Tunisia
  • Fattouma Bourguiba University Hospital of Monastir
    Monastir, 5000, Tunisia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05149417
Lead sponsor
University of Monastir
Responsible party
Pr. Semir Nouira (chief of the Emergency departement in CHU fattouma Bourguiba Monastir , PhD, University of Monastir) — Principal investigator
First posted
Dec 8, 2021
Start date
Aug 21, 2020
Primary completion
May 21, 2022
Completion
Jul 31, 2022
Last update
Aug 10, 2022

Oversight

Data monitoring committee
Yes
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 Aug 2022. You cannot join it, but the record below documents what was studied.

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