- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05555082
Can Massage During One Year Improve Health in Health-care Providers Working in Hospital
February 15, 2023 updated by: Peter Johansson, University Hospital, Linkoeping
The overall aim of this pilot study is to investigate the effect, "feasibility" and experiences of regular massage over 12 months on the mental and physical health of healthcare professionals, as well as the frequency of layoffs, sick leave and reported patient safety risk cases, as well as health economics
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
A pilot and "feasibility" study with pre-post design.
50 health care professionals from the Medical Clinic, Vrinnevi Hospital in Norrköping are included.
The participants perform 10 30 minute sessions of classic Swedish massage during 12 months by a certified masseur.
Mental and physical health data is collected using questionnaires, blood and body weight.
Data on layoffs, sick leave and patient safety risks are taken from the hospital's data register.
Data regarding the participants' experience of receiving massages is collected during interviews.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lena Ekströn, Manager
- Phone Number: 010-1043519
- Email: Lena.Ekstrom@regionostergotland.se
Study Contact Backup
- Name: Peter Johansson, Professor
- Phone Number: +46460700896548
- Email: peter.b.johansson@liu.se
Study Locations
-
-
-
Norrköping, Sweden, 601 74
- Recruiting
- Linköping University
-
Contact:
- Lena Ekströn
- Phone Number: 0101043519
- Email: Lena.Ekstrom@regionostergotland.se
-
Contact:
- Peter PJ Johansson, PhD
- Email: peter.b.johansson@liu.se
-
-
Linköpings Universitet
-
Norrköping, Linköpings Universitet, Sweden, 601 74
- Recruiting
- Peter Johansson
-
Contact:
- Peter Johansson
- Phone Number: +46460700896548
- Email: peter.b.johansson@liu.se
-
Contact:
- Lena Ekströn
- Phone Number: 0101043519
- Email: Lena.Ekstrom@regionostergotland.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Working at least for 50 % of fulltime
Main task working with patient care in the hospital ward
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Massage
30 minutes of classical swedish massage given by a certified masseur 10 times monthly during 12 months
|
10 times of 30 minutes Swedish classical Massage will be given monthly during one year.
The massage will be give by a cerified masseur
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of stress
Time Frame: change in Percieved Stress Scale-10 mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 40. A higher score means more stress
|
Percieved Stress Scale-10
|
change in Percieved Stress Scale-10 mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 40. A higher score means more stress
|
Symptoms of depression
Time Frame: change in Patient Health Questionnaire-9 mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 27. A higher score means more depressive symptoms
|
Patient Health Questionnaire-9
|
change in Patient Health Questionnaire-9 mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 27. A higher score means more depressive symptoms
|
Sleeping problems
Time Frame: change in Insomnia Severity Index mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 28. A higher score means more sleeping problmes
|
Insomnia Severity Index
|
change in Insomnia Severity Index mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 28. A higher score means more sleeping problmes
|
Symptoms of anxiety
Time Frame: change in General Anxiety Disiorder mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 21. A higher score means more anxiety
|
General Anxiety Disorder-7
|
change in General Anxiety Disiorder mean score from baseline (start of massage) to 12 months (end of massage). Score can range from 0 to 21. A higher score means more anxiety
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Staff turnover
Time Frame: the number of sick leave days during the 12 months internvetion period will be compared to the numbers of sicke leave days the previous year. Data will be collected from the hospitals datajournal system
|
Sick leave days
|
the number of sick leave days during the 12 months internvetion period will be compared to the numbers of sicke leave days the previous year. Data will be collected from the hospitals datajournal system
|
Health Related Quality of life
Time Frame: change in the eight health concept scores and the two summary component scores of the RAND-36 from baseline (start of massage) to 12 months (end of massage). Scores range from 0 to 100. A higher score means a better health related quality of life
|
The RAND-36
|
change in the eight health concept scores and the two summary component scores of the RAND-36 from baseline (start of massage) to 12 months (end of massage). Scores range from 0 to 100. A higher score means a better health related quality of life
|
Global Quality of life
Time Frame: change in Visual Analog Scale from EQ-5D score from baseline (start of massage) to 12 months (end of massage). The scale ranges from 0 to 100. A higher score means a better quality of life
|
Visual Analog Scale from EQ-5D
|
change in Visual Analog Scale from EQ-5D score from baseline (start of massage) to 12 months (end of massage). The scale ranges from 0 to 100. A higher score means a better quality of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Johansson, Professor, Linköpings Universiet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2022
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
December 30, 2024
Study Registration Dates
First Submitted
September 15, 2022
First Submitted That Met QC Criteria
September 22, 2022
First Posted (Actual)
September 26, 2022
Study Record Updates
Last Update Posted (Estimate)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2020-01140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At our university we have not yet any plan on how to deal with GDPR and sharing data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
Clinical Trials on Massage
-
Chulalongkorn UniversityCompletedIschemic StrokeThailand
-
TC Erciyes UniversityCompletedAbdominal Pain | Satisfaction, Patient | DistentionTurkey
-
Mayo ClinicCompletedFatigue | Stress | Anxiety | TensionUnited States
-
São Paulo State UniversityFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of ValenciaCompletedHamstring ContracturesSpain
-
muxing zhuRecruiting
-
Emre ErkalRecruiting
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedMusculoskeletal ManipulationsFrance
-
Mersin UniversityCompletedHemodialysis PatientsTurkey
-
Universitat Internacional de CatalunyaUnknown