PainNCT07157709
Implementation of the Pain Management Toolkit
A study testing non-pharmacological interventions in people with Pain, run by Medizinische Universität Graz, Institut für Pflegewissenschaft at 1 site in Austria.
Trial summary
The overall aim of this research study is to implement and evaluate the toolkitinto the nursing home by using scientific methods, which is cut down in specific aims. 1. To assess the effectiveness of the toolbox on 1. staff outcomes 2. pain management practice 3. resident's outcomes 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- non-pharmacological interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of pain
- living in the collaborating nursing home
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of the Pain Management Toolkit in a Nursing Home
The overall aim of this research study is to implement and evaluate the toolkitinto the nursing home by using scientific methods, which is cut down in specific aims.
- To assess the effectiveness of the toolbox on
- staff outcomes
- pain management practice
- resident's outcomes
- To identify potential barriers and facilitators of the implementation from the perspective of the staff
- To investigate different outcomes of the implementation strategies
- Conditions
- Pain
- Being tested
- non-pharmacological interventions
- Keywords
- pain, pain management, implementation, toolkit, non-pharmacological, long term care
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-pharmacological interventionsOther
Also called Empathic attention and communication, Physical exercise, Relaxation techniques, Self-hypnosis and fantasy journeys
Care staff collaborate with residents to select the most suitable non-pharmacological intervention from the designated toolkit to reduce pain. It is imperative to pay attention to the resident's preferences and to ascertain which intervention they would like to attempt.
| Study group | Role | What they receive |
|---|---|---|
| non-pharmcological interverntions to reduce pain | Experimental | non-pharmacological interventions will be administered in order to treat pain Receives: Other: non-pharmacological interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing staff self-efficacy in pain management (self-efficacy in pain management scale)
The self-efficacy from the nursing staff with regard to pain management will be assessed by the self-efficacy in pain management scale developed by Brunkert et al. in 2019.
Measured: 1 year
Pain management process indicator: number of non-pharmacological measures
This data will be collected from the nursing home resident's record - the last 7 days will be assessed.
Measured: 1 year
Pain management process indicator: number/dosage of pain medication
This data will be collected from the nursing home resident's record - the last 7 days will be assessed.
Measured: 1 year
Resident's outcome indicator: frequency of pain
The frecquency of documented pain in the last 7 days will be assessed, by going through the nursing home resident's records.
Measured: 1 year
Resident's outcome indicators: pain intensity
Pain intensity will be assessed by the documented pain in the nursing home resident's records. The most recent pain intensity score will be used.
Measured: 1 year
Resident's outcome indicators: pain impairment (PEG scale)
The pain impairment will be assessed by using the PEG scale developed by Wander et al. in 2022.
Measured: 1 year
Resident's outcome indicators: quality of life (VAS scale)
The EQ-5D VAS is an internationally well-known, valid and reliable instrument to assess quality of life in adults in will be used to assess health related quality of life.
Measured: 1 year
Secondary outcomes (2)
Staff's perception about implementation barriers (pCAT)
To assess staff's perception about implementaiton barrieres, the pCAT questionnaire will be used.
Measured: 1 year
Staff's perception about implementation facilitators (pCAT)
To assess staff's perception about implemenation facilitators, the pCAT questionnaire will be used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jul 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medizinische Universität Graz, Institut für Pflegewissenschaft
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Hoedl, Medizinische Universität Graz, Institut für Pflegewissenschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157709
- Sponsor's protocol ID
- EK Nr:1371/2024
- Other IDs
- CM-300
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Pain Management Toolkit in a Nursing Home
- ClinicalTrials.gov ID
- NCT07157709
- Acronym / sponsor ID
- EK Nr:1371/2024
- Conditions
- Pain
- Keywords
- pain, pain management, implementation, toolkit, non-pharmacological, long term care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medizinische Universität Graz, Institut für PflegewissenschaftUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Sep 2025 (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 overall aim of this research study is to implement and evaluate the toolkitinto the nursing home by using scientific methods, which is cut down in specific aims.
- To assess the effectiveness of the toolbox on
- staff outcomes
- pain management practice
- resident's outcomes
- To identify potential barriers and facilitators of the implementation from the perspective of the staff
- To investigate different outcomes of the implementation strategies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-pharmcological interverntions to reduce pain | Experimental | Other: non-pharmacological interventionsnon-pharmacological interventions will be administered in order to treat pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of pain
- living in the collaborating nursing home
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| non-pharmacological interventionsAlso: Empathic attention and communication, Physical exercise, Relaxation techniques, Self-hypnosis and fantasy journeysCare staff collaborate with residents to select the most suitable non-pharmacological intervention from the designated toolkit to reduce pain. It is imperative to pay attention to the resident's preferences and to ascertain which intervention they would like to attempt. | Other | non-pharmcological interverntions to reduce pain |
Primary outcome
Nursing staff self-efficacy in pain management (self-efficacy in pain management scale)
Time frame: 1 year
The self-efficacy from the nursing staff with regard to pain management will be assessed by the self-efficacy in pain management scale developed by Brunkert et al. in 2019.
Pain management process indicator: number of non-pharmacological measures
Time frame: 1 year
This data will be collected from the nursing home resident's record - the last 7 days will be assessed.
Pain management process indicator: number/dosage of pain medication
Time frame: 1 year
This data will be collected from the nursing home resident's record - the last 7 days will be assessed.
Resident's outcome indicator: frequency of pain
Time frame: 1 year
The frecquency of documented pain in the last 7 days will be assessed, by going through the nursing home resident's records.
Resident's outcome indicators: pain intensity
Time frame: 1 year
Pain intensity will be assessed by the documented pain in the nursing home resident's records. The most recent pain intensity score will be used.
Resident's outcome indicators: pain impairment (PEG scale)
Time frame: 1 year
The pain impairment will be assessed by using the PEG scale developed by Wander et al. in 2022.
Resident's outcome indicators: quality of life (VAS scale)
Time frame: 1 year
The EQ-5D VAS is an internationally well-known, valid and reliable instrument to assess quality of life in adults in will be used to assess health related quality of life.
2 secondary outcomes
Staff's perception about implementation barriers (pCAT)
Time frame: 1 year
Staff's perception about implementation facilitators (pCAT)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-pharmacological interventions in people with Pain, run by Medizinische Universität Graz, Institut für Pflegewissenschaft at 1 site in Austria.
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 2 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 5 Sep 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
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?
Nursing staff self-efficacy in pain management (self-efficacy in pain management scale) (time frame: 1 year). The study lists 7 primary outcomes in all. 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 5 Sep 2025.