Low Back PainNCT04610073
The Effect of Interactive Multimedia Versus Illustrated Booklet on Behavior to Prevent Lower Back Pain in Working Nurses.
A study testing Interactive multimedia training and illustrated booklet in people with Low Back Pain, run by Nahid Zarifsanaiey at 1 site in Iran.
Trial summary
The present study was conducted to compare the effect of interactive multimedia and illustrated booklet methods on knowledge, attitude and improvement of behavior in preventing lower back pain amongst lower back pain amongst nurses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Interactive multimedia training and illustrated booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteIran
- Study dates
- 30 Jun 2019to 29 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Minimum education level of bachelor's degree in nursing
- Employment in governmental hospitals
- Willing to participate in the study and complete the informed consent
- Minimum knowledge of working with computers
Who cannot join
- Congenital anomalies
- low back pain
- History of back surgery
- History of trauma to the back
- Pregnancy
- Severe osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Interactive Multimedia Versus Illustrated Booklet on Behavior to Prevent Lower Back Pain in Working Nurses in the Hospitals Affiliated to Shiraz University of Medical Sciences.
The present study was conducted to compare the effect of interactive multimedia and illustrated booklet methods on knowledge, attitude and improvement of behavior in preventing lower back pain amongst lower back pain amongst nurses.
Read the detailed description
In this single blind randomized controlled trial, 153 eligible nurses working in hospitals during 2019 were enrolled. The participants were randomly allocated into three parallel groups: interactive multimedia (n=55), illustrated booklet (n= 55), and the control (n= 43). The study samples were blinded to intervention and control groups. A researcher-made questionnaire was completed by the eligible subjects before, after, and four weeks after the intervention to assess their knowledge, attitude and behavior in preventing chronic lower back pain amongst working nurses.
- Conditions
- Low Back Pain
- Being tested
- Interactive multimedia training and illustrated booklet
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive multimedia training and illustrated bookletBehavioural
The experimental groups conducted interactive multimedia training and illustrated booklet
| Study group | Role | What they receive |
|---|---|---|
| Interactive multimedia training | Experimental | the intervention group 1 completed the pretest knowledge, attitude, and behavior questionnaire. Then, interactive multimedia was made available to this group. The questionnaire was completed again by the group, one week after completion of training, and then one month afterward. Receives: Behavioral: Interactive multimedia training and illustrated booklet |
| illustrated booklet | Experimental | First, the intervention group 2 completed the pretest knowledge, attitude, and behavior questionnaire. Then, illustrated booklet was made available to this group. The questionnaire was completed again by the group one week after completion of training, and then one month afterward. Receives: Behavioral: Interactive multimedia training and illustrated booklet |
| No Intervention | Experimental | In the control group, no intervention was performed. Only before the intervention, one week and one month after the intervention, they completed the knowledge, attitude and behavior questionnaires. Receives: Behavioral: Interactive multimedia training and illustrated booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior of the employed nurses in order to prevent low back pain
Researcher made questionnaire for measuring behavior with 19 questions based on a six-point Likert scale.
Measured: 5 weeks
Secondary outcomes (2)
Knowledge of the employed nurses in order to prevent low back pain
A Researcher made questionnaire for measuring knowledge with 10 four-option questions.
Measured: 5 weeks
Attitude of the employed nurses in order to prevent low back pain
A researcher made questionnaire for measuring attitude with 18 questions based on a six-point Likert scale.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start30 Jun 2019
- Primary completion28 Jul 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nahid Zarifsanaiey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nahid Zarifsanaiey, Shiraz University of Medical Sciences
- Investigators
- Nahid zarifsanaiey, PhD, Principal investigator, associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610073
- Sponsor's protocol ID
- IR.SUMS.REC.1397.1093
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Interactive Multimedia Versus Illustrated Booklet on Behavior to Prevent Lower Back Pain in Working Nurses in the Hospitals Affiliated to Shiraz University of Medical Sciences.
- ClinicalTrials.gov ID
- NCT04610073
- Acronym / sponsor ID
- IR.SUMS.REC.1397.1093
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Nahid ZarifsanaieyUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 28 Jul 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was conducted to compare the effect of interactive multimedia and illustrated booklet methods on knowledge, attitude and improvement of behavior in preventing lower back pain amongst lower back pain amongst nurses.
Detailed description
In this single blind randomized controlled trial, 153 eligible nurses working in hospitals during 2019 were enrolled. The participants were randomly allocated into three parallel groups: interactive multimedia (n=55), illustrated booklet (n= 55), and the control (n= 43). The study samples were blinded to intervention and control groups. A researcher-made questionnaire was completed by the eligible subjects before, after, and four weeks after the intervention to assess their knowledge, attitude and behavior in preventing chronic lower back pain amongst working nurses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive multimedia training | Experimental | Behavioral: Interactive multimedia training and illustrated bookletthe intervention group 1 completed the pretest knowledge, attitude, and behavior questionnaire. Then, interactive multimedia was made available to this group. The questionnaire was completed again by the group, one week after completion of training, and then one month afterward. |
| illustrated booklet | Experimental | Behavioral: Interactive multimedia training and illustrated bookletFirst, the intervention group 2 completed the pretest knowledge, attitude, and behavior questionnaire. Then, illustrated booklet was made available to this group. The questionnaire was completed again by the group one week after completion of training, and then one month afterward. |
| No Intervention | Experimental | Behavioral: Interactive multimedia training and illustrated bookletIn the control group, no intervention was performed. Only before the intervention, one week and one month after the intervention, they completed the knowledge, attitude and behavior questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum education level of bachelor's degree in nursing
- Employment in governmental hospitals
- Willing to participate in the study and complete the informed consent
- Minimum knowledge of working with computers
Key exclusion criteria (6 listed)
- Congenital anomalies
- low back pain
- History of back surgery
- History of trauma to the back
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive multimedia training and illustrated bookletThe experimental groups conducted interactive multimedia training and illustrated booklet | Behavioural | Interactive multimedia training, No Intervention, illustrated booklet |
Primary outcome
Behavior of the employed nurses in order to prevent low back pain
Time frame: 5 weeks
Researcher made questionnaire for measuring behavior with 19 questions based on a six-point Likert scale.
2 secondary outcomes
Knowledge of the employed nurses in order to prevent low back pain
Time frame: 5 weeks
Attitude of the employed nurses in order to prevent low back pain
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahid zarifsanaiey, PhD principal investigator
associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive multimedia training and illustrated booklet in people with Low Back Pain, run by Nahid Zarifsanaiey at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior of the employed nurses in order to prevent low back pain (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.