NCT07157709

Brief 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. 1.To assess the effectiveness of the toolbox on
  2. 2.staff outcomes
  3. 3.pain management practice
  4. 4.resident's outcomes
  5. 5.To identify potential barriers and facilitators of the implementation from the perspective of the staff
  6. 6.To investigate different outcomes of the implementation strategies

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
4mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2025Sep 2026

Study Start

First participant enrolled

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 18, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

painpain managementimplementationtoolkitnon-pharmacologicallong term care

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    1 year

Secondary Outcomes (2)

  • Staff's perception about implementation barriers (pCAT)

    1 year

  • Staff's perception about implementation facilitators (pCAT)

    1 year

Other Outcomes (3)

  • Staff's perception about the appropriateness of the toolkit (IAM scale)

    1 year

  • Staff's perception about the feasibility of the toolkit (IAM scale)

    1 year

  • Penetration of the toolkit (FIM scale)

    1 year

Study Arms (1)

non-pharmcological interverntions to reduce pain

EXPERIMENTAL

non-pharmacological interventions will be administered in order to treat pain

Other: non-pharmacological interventions

Interventions

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.

Also known as: Empathic attention and communication, Physical exercise, Relaxation techniques, Self-hypnosis and fantasy journeys, Relieving pressure on affected body parts/positioning, Distraction, Promoting sleep, Psychological support, Cold application, Heat application, Wraps and compresses, Laughter therapy, Massage, Music, Aromatherapy: massage with essential oils, Aromatherapy: gargling with essential oils, Aromatherapy: inhalation of essential oils, Aromatherapy: lymphatic drainage with essential oils, Mindfulness exercises
non-pharmcological interverntions to reduce pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of pain
  • living in the collaborating nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

ExerciseRelaxation TherapyHypnosisPatient PositioningOsteogenesis, DistractionLaughter TherapyMassageMusic TherapyOils, Volatile

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareHealth ServicesHealth Care Facilities Workforce and ServicesBone LengtheningOrthopedic ProceduresSurgical Procedures, OperativeTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy ModalitiesRehabilitationSensory Art TherapiesAftercareContinuity of Patient CareOilsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Ass. Priv.-Doz. Dr.rer.cur. BSc MSc

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 5, 2025

Study Start

July 1, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations