Comparing Two Types of Dynamic Air Mattresses, With Focus on Changes in Pressure Injury Occurrence and Functionality
Phase: NA
Conditions: Pressure Injury, Sleep, Pain, Satisfaction, Patient, Noise Exposure, Strains, Satisfaction, Personal
Sponsor: Sunnaas Rehabilitation Hospital

 
 
 
NCT number: NA 
Sunnaas Rehabilitation Hospital, Departments of Spinal Cord Injury, Multi-trauma, 
Neurology and Burns,  
January 1st 2022 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Cross-over Trial, 
testing 
Dynamic Air Mattresses 
Assessment of pressure injury risk and mattress functionality  
 
 

Dynamic Air Mattresses 
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Content 
 
Preface ........................................................................................................................................ 3 
Testbed and Tidewave ............................................................................................................ 3 
Introduction ................................................................................................................................ 4 
Technical information regarding the mattresses ..................................................................... 5 
Contamination procedures ...................................................................................................... 5 
The purpose of the study ............................................................................................................ 6 
    Troubleshooting                                                                                                                                                 
Comparing the mattresses in relation to; .................................................................................... 6 
Development of PI risk ........................................................................................................... 6 
Material and Methods ................................................................................................................. 6 
    Research design ...................................................................................................................... 6 
    Testing the matrasses ...................................................... Feil! Bokmerke er ikke definert.7 
    Selection .......................................................................... Feil! Bokmerke er ikke definert.7 
    Power calculation……………………………………………………………………………7 
    Inclusion citeria ...................................................................................................................... 7 
    Exclusion criteria .................................................................................................................... 8 
Procedure ................................................................................................................................ 8 
    Collection of data and assessment instruments ...................................................................... 9 
Demographic data ................................................................................................................... 9 
    Primary Outcome Measure ..................................................................................................... 9 
    Secondary Outcome Measures ............................................................................................... 9 
Ethical considerations .............................................................................................................. 10 
Data processing/statistics ......................................................................................................... 10 
Consumer perspective .............................................................................................................. 11 
Insurance .................................................................................................................................. 11 
Milestones ................................................................................................................................ 11 
Economy ................................................................................................................................... 11 
Project organization .................................................................................................................. 11 
Dissemination ........................................................................................................................... 13 
References ................................................................................................................................ 13 
 

Dynamic Air Mattresses 
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Preface Testbed and Tidewave 
Innovation at Sunnaas Rehabilitation Hospital (SunHF) has a main focus on better health 
services and methods of treating patients. With an increasing amount of development and 
innovation projects connected to private or public businesses, SunHF decided to set up a 
service that could facilitate the cooperation between business and the hospital. Thus, Testbed 
was created as an arena where business and health care can work together to test, develop and 
implement new products, services, methods, and organizational solutions.  
In 2019, Tidewave R&D and SunHF began discussing the prospect of assessing the newly 
developed Tidewave turning mattress (Tidewave). The development of Tidewave is based on 
a systematic review on the role of repositioning in the prevention of pressure injury (2018)1, 
in addition to a pressure test performed by the Norwegian Research Center2 (NORCE 
2018/19). Patients at SunHF are potential users of this turning mattress, and it are therefore 
important candidates to test the mattress with focus on the product`s quality regarding 
functionality and pressure injury (PI) prevention. One of the patient groups that would 
potentially benefit from the matrass is individuals with spinal cord injuries, which is also one 
of the main patients groups at the hospital. In the trial, Tidewave will be compared with the 
recommended CuroCell® 4 AD (CuroCell) mattress to investigate the quality of the product 
with in particular focus on individuals with spinal cord injury (SCI).  
 
January 1st 2022 
Lene Mosberg og Ingebjørg Irgens  
 
 

Dynamic Air Mattresses 
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Introduction 
Sunnaas Rehabilitation hospital delivers acute rehabilitation to patients suffering from newly 
acquired injuries related to the spinal cord, as well as to the muscular and skeletal structure. 
The acute rehabilitation takes place from the departments focusing on spinal cord injury 
sequelae (RMS), and the department of multi trauma, neurology and burns (MNB). Newly 
injured individuals are admitted from the acute care hospital as soon as they are ready and in a 
condition to start their multidisciplinary rehabilitation program. In 2019, 82 patients, with a 
mean age of 56 years, received their acute rehabilitation at one of these two facilities. The 
mean length of stay was 71 days. After the rehabilitation, 63 (77%) of the patients were 
discharged to home, 8 (10%) to other hospitals, 7 (8%) to private rehabilitation facilities and 4 
(5%) to nursing homes3. Individuals with paralysis and individuals recovering after multiple 
trauma has increased risk of pressure injury (PI) development, compared to individuals not 
suffering such injuries or diseases4-6. This is due to lack of sensibility, reduced or lack of 
voluntary mobility and areas of the skin being exposed to unfavourable moisture from 
sweating and incontinency7-9. Individuals with PI are often hospitalized over increased time-
periods and are exposed to an increased number of outpatient consultations related to PI 
treatment and follow-up10. PI causing infection can potentially expose patients to life-
threatening conditions8,9. PI can also cause increased pain, tension and sleep deprivation. PI 
prevalence assessments performed at RMS and MNB in 2019 indicated that a major portion 
of the hospitalized patients were at risk of having a PI, and that 29% of the examined 
population at the two departments had a PI. This finding confirmed the importance and value 
of risk reducing intervention. The assessment also elaborated that the PIs occurred at areas of 
the body that are exposed to pressure over time, whilst in a supine position, e.g. such hips, 
buttock and heels. A long-time supine position demands a need for manual turning and, thus a 
waking of the individual during the night if the mattress is a standard static version. On the 
other hand, dynamic air mattresses are widely in use today, focusing on a variation in 
pressure, and thus a reduced need of position change during the imbedded time lap. Even 
though these mattresses reduce the need for manual turning, they do not eliminate the problem 
for individuals who are not capable of managing the position change on their own, and some 
individuals require position change assistance every second hour. The European Pressure 
Ulcer Advisory Panel’s (EPUAP) 2019 guidelines11 recommend an average of  position 
change every second to forth hour. Further, they advise individuals at risk of PI development 
to be positioned in a 30-degree sideways posture11.  

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Dynamic air mattresses represent a variation of quality, related to pressure variation of the 
mattress to prevent PIs. This pressure variation is due to automatic air change offered by an 
automatic air pump system. However, the noise generated by the pump could disturb the 
sleep, causing a decrease in quality of life over time. 
Technical information regarding the mattresses                                                                     
The intervention mattress, Tidewave, is a dynamic air mattress which automatically turns the 
patient from side to side with a maximum angle of 30 degrees at each side, over the course of 
a maximum of 180 minutes. When inflated, the mattress shape and retains a cradle formation, 
which in favour of increasing comfort and safety for the patient. The cradle shape provides a 
10% increase in pressure distribution, in comparison to traditional posture alteration. In 
addition, the mattress provides a pressure relief caused by the continuous movement of the 
individual. The mattress is designed to be comfortable, increase sleep quality and reduce the 
amount of manual position changes required from the nursing staff. The mattress has three 
variations of weight recommendations, ranging upwards to a maximum of 150 kilos. The 
mattress has been tested in nursing homes, in individuals` homes and hospitals. The 
Norwegian Medicines Agency (NO918491775/0941-55297) has approved the mattress, and 
the mattress conforms to the European Regulation 2017/745, with a risk class 1 as per rules in 
Annex VIII. The developer, Tidewave R&D, started mass production of the product in 
October 2020. 
The control mattress, CuroCell® 4 AD, is a dynamic mattress providing pressure variation 
and in prevention and treatment of PIs, this can be utilized. The mattress is functional and 
provides satisfying comfort for the individual. The removable bedsheet isdocumented to have 
a high hygiene standard, and is designed to allow moisture to pass through, reducing the risk 
of moisture related injuries to the skin. The mattress offers a variety of attributes, such as a 
heel function that reduces strain on exposed/sensitive heels. Recommended weight ranges 
from 0 – 200 kg. The mattress is in Sunnaas Rehabilitation hospital currently used as first of 
choice mattress to individuals at risk of PI development. 
Contamination procedures 
The hospital has established and implemented cleaning and disinfection procedures in 
accordance with current national regulations. These procedures will be followed throughout 
the project. This is especially important in contamination-related situations.  

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The purpose of the study  
To compare an intervention mattress and a regular care mattress in relation to occurrence of 
pressure-relief, experienced sleep comfort, pain and quality of life in the participants. Further, 
to examine resources needed to assist in position change of the participants, as well as 
physical strain for the nurses. 
Troubleshooting                                                                                                                    
Compare the Tidewave turning mattress (intervention mattress) to the CuroCell® 4 AD 
(control mattress) in relation to;  
1) Development of PI risk 
2) Noise disturbance, pain, quality of life, quality of sleep, general bedrest comfort.  
3) Functionality in terms of daily use, such as getting dressed and repositioning to and 
from the bed.   
4) Resource use in staff members with focus on amount of required manual position 
changes during the day, as well as number of staff members required for each manual 
position change, and the level of physical exertion required from the hospital staff to 
perform the position changes. 
Material and Methods 
Research design  
To conduct a prospective cross over testing, with ten participants from the group of patients at 
the two acute rehabilitation departments.                                                                      
A feasibility study was in advance of the main trial completed. The results from the 
feasibility trial supported the choice of inclusion and exclusion criteria regarding safety in the 
participants while testing the mattresses. Acceptable pressure limits were set, based on the 
findings in the feasibility study, as well as evidence-based knowledge regarding level of 
pressure and risk of PI12. The feasibility study was performed between May 4th to 7th 2021. 
Based on the results from the feasibility study, relevant validated and custom-made 
questionnaires were chosen to get the needed information regarding the participants` 
experience being bed rested on the mattresses. Custom-made questionnaires regarding 
experienced strain, resource use and physical exertion in the group of staff members was 

Dynamic Air Mattresses 
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developed. As well as two semi-structured questionnaires, focusing on in-depth knowledge of 
the participants’ and the staff members` experience with the mattresses, respectively.  
 Selection of participants 
Three to four weeks after admission to the RMS or MNB departments, between September 
2021 and December 2022, ten participants will be included in the study. Participants included 
in the trial will suffer from SCI, neurological disease with paralysis or multi trauma. All with 
the consequence of decreased self-dependency and mobility, and thus lack of independency in 
position change in bed.  The selection of candidates will be by the project nurse, based on the 
inclusion criteria, and in accordance with the responsible physician at the department. The 
duration for each participant will be 14 days, seven days on each of the mattresses. The 
project nurse will contact potential participants in person, provide oral information about the 
study, hand out written project information, as well as an invitation to participate. 
Power calculation 
The sample size calculation is based on the Insomnia Severity Scale (ISS) validation study by 
Morin et al (2011)13. The hypothesis is that the sleep will improve when using the 
intervention mattress, as compared to the control mattress. However, the expectation is a low 
improvement, due to the low period of time the intervention mattress will be in use. Thus, the 
sample size calculation will be based on what is denoted a “slight improvement”, defined by 
Morin et.al. as an improvement on 4.6 points on the ISS scale13. Based on this effect, a power 
of 0.8 and a significance level of 0.05, will need eight participants, given the set assumptions 
regarding variation (SD = 4.5, taken from Morin et. al). Thus, we include 10 participants to 
tolerate some drop- outs.  
Inclusion citeria 
 > 18 years of age 
 SCI, neurological disease with paralysis or multi trauma, all with lack of 
independency in position change in bed Hospitalized for primary rehabilitation in 
either the RMS or the MNB department 
 Requires manual position change 
 Medically approved for the participation by the patient’s physician 
 Able to consent to participate 
 Psychically and cognitively able to properly answer the questionnaires 

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 Speaks/understands Norwegian language 
Exclusion criteria 
 Ongoing PI upon admission to the hospital  
 External fixation, except use of neck-collar 
 Body weight surpassing the mattress limits 
 Pressure testing indicating a worse result than the set pressure limit  
 The participant has a planned leave of absence during night time, during the test-
period 
Procedure                                                                                                                                            
To secure safe use of the intervention mattress, a noise-test and a pressure assessment test of 
the mattresses has been performed in advance of the research project. A pressure limit is 
defined, based on current evidence based knowledge regarding pressure injury risk. If this 
limit is exceeded during the project period, the participant will be excluded from further 
testing, due to a potential increased risk of pressure injury development.  
An Xsensor mat14 will be used in all pressure assessments. Written and oral information 
regarding the project will be given. The participants will give a written consent before 
inclusion. The regular care mattress, used as control in this trial, is considered one of the best 
pressure relieving mattresses available in Norway, and this mattress is the mattress of choice 
when the patient is admitted to the spinal cord unit for post-acute rehabilitation. Due to the 
randomized cross over design of the study, the start mattress will be chosen according to the 
randomization. The test-period will start with one of the mattresses for seven days, and then 
change back to the other mattress after seven days. This to secure a best possible objective 
comparison between the two mattresses. The study will be open labelled, because it will be 
impossible to mask the mattresses due to different designs. Ten participants will be included. 
Baseline data regarding gender, age, level and severity of the spinal injury, together with 
pressure injury associated dysfunction, like increased sweat, bladder and bowel incontinency, 
will be collected immediately after inclusion. Further, information of comorbidity previous to 
the injury or disease, including cardiovascular disease, embolisms or diabetes mellitus, will be 
registered. Pressure monitoring will be performed before start up, and validated 
questionnaires will be used in assessing pressure injury risk, pain and quality of life (QoL). 
After seven days use of the first mattress, new data will be collected, by means of validated 
forms regarding pressure injury occurrence, pain occurrence, noise from the mattress devices, 

Dynamic Air Mattresses 
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sleeping wellness and participant satisfaction. Custom made forms regarding resource use in 
the nursing staff, especially at night and in relation to position change, will be collected, 
together with data regarding physical strain in the staff. In-depth interviews will be performed 
on one participant and one nurse. 
The participant will then change to the second mattress and use the mattress for seven days. 
Then a new data collection will be performed, similar to the questionnaires used in the first 
mattress. In-depth interviews will be performed in one participant and one nurse. 
Collection of data and assessment instruments  
At every shift during the project period, the nurses will check for pressure wounds, and mark 
identified pressure wounds on a pressure injury body-map. At every shift the nurses will also 
use a custom made form to register resources needed in each position changing of the patient, 
the number of times the position is changed, as well as the level of physical strain in the 
nurses. At the end of each of the two the test periods, the participants will register their QoL, 
bedrest comfort, sleep-wellness, pain and satisfaction in the test period.  
One participant and one nurse will be asked to participate in in-depth interviews regarding 
experienced quality in use and in managing each of the mattresses.                                                                     
Demographic data 
Will be retrieved from the electronic patient record (EPR), and include gender, age, height 
and weight, injury-related information, time between the occurrence of the SCI as well as 
known injury-related risks, related to PI.    
Primary Outcome Measure  
Pressure Injury risk.  
Assessment of PI risk will be performed via the Braden scale15. Every morning an evening 
any PI occurrence will be performed according to the NPIAP, 2019 Clinical Practice 
Guideline16, and any new mark/PI will be noted and rated on a severity scale ranging from 1 
to 4. The location of the mark/PI will be marked on a body map chart, displaying the location 
of the mark/PI. 
Secondary Outcome Measures 
Health related quality of Life (HRQoL) regarding overall well-being, physical well-being and 
psychological well-being. Assessment will be performed using the spinal cord injury quality 

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of life basic data set (SCI QoL BDS)17. Assessment will be performed at baseline, at change 
of mattress and at end of study.                                                                                                         
Sleep wellness assessment will be performed, using the Insomnia Severity Index (ISI)18. 
Assessment will be performed at baseline, at change of mattress and at end of study. 
Experienced pain when using the two mattresses will be assessed by using the Brief Pain 
Inventory (BPI)19. Assessment will be performed at baseline, change of mattress and at end of 
study.                                                                                                                                            
Satisfaction in participants will be assessed using a custom-made Likert scale where 1 is 
completely dissatisfied and 5 is totally satisfied. Assessment will be performed at baseline, at 
change of mattress and at end of study.  
Satisfaction in staff will be assessed as resource-use, counting the number of personnel 
needed, number of manual turnings required/level of required support during daytime/night-
time, and physical strain in the nursing staff, using a custom made Likert scale where 1 is 
worst possible strain and 5 is no strain at all. Assessment will be performed at baseline, at 
change of mattress and at end of study. 
A custom made semi-structured interview guide has been conducted, asking more details of 
the experienced quality in use and in managing the mattress. 
Ethical considerations   
The patient will be excluded from the study if risk of increased PI is apparent during the pre-
test pressure mapping. The risk is determined by the pre-set pressure measurement limit. 
The project will follow the national regulations regarding approval, collection and handling of 
sensitive data. Privacy regulations will be followed. The Tidewave mattress was approved by 
the Norwegian Medicines Agency (SLV) November 25th 2020, (NO918491775/0941-55297) 
and evaluated not to be included in the Ethical Committee`s (REK) area of responsibility, 
January 15th 2021 (229188), and by the Patient Ombudsman at Sunnaas Rehabilitation 
hospital, September 16th 2021. Written and oral information will be given to all invited 
participants, and the participants have the right to withdraw from the project without giving 
any reason for the withdrawal.  
Data processing 
All data will be anonymized and stored at the hospital’s encrypted data server. This is in line 
with the Norwegian privacy and data protection legislation. The data be available solely to 
individuals connected to the project. Any privacy information that can identify participants 
will be stored separately from the rest of the data. The letter of consent and the answers to the 

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questionnaires will be stored in a secure research cabinet. The keys to the cabinet are be 
stored securely. The data will be deleted 15 years after the conclusion of the study. Latest date 
of deletion is 1st of September 2037.    
Consumer perspective 
An experienced consumer and two representatives from the Norwegian Spinal Cord Injury 
Association (LARS) will participate in the study, to ensure the quality of the procedures and 
make sure the actions are performed in an ethically suitable manner. 
Insurance 
The participants in the study are insured via the hospital`s insurance program. 
Milestones 
WHEN 
WHAT 
Week 15, 2021 
Feasibility 
Week 36, 2021 
Preparation 
Week 39, 2021 
Start Inclusion 
Week 26, 2022 
Start data processing 
Weeks 33, 2022 
Start writing study article 
Week 50, 2022 
Submitting article 
Economy 
Tidewave is funding the study as well as providing the required equipment and services for 
the pressure assessments. Sunnaas Rehabilitation hospital has the ability to purchase the 
equipment after the conclusion of the study. The researchers will perform all tests, data 
punching and analyses. The researchers will write a final report to Tidewave. The researchers 
will write and submit an article to a peer-reviewed journal, based on the results from the 
study.  
Project organization  
The managers from the Innovation department, Clinic, Clinical departments and Research 
department will represent the management group. The project group is responsible for the 

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planning and follow-up through of the project. The project group consists of nurses, 
physicians, occupational therapists and physiotherapist. All members with thorough 
knowledge of PI, PI prevention and pressure measurement.                                                     
The expanded project group will be invited to project meetings before the project initiates, 
and every second to third month afterwards. 
Group 
Department 
Members 
Assignment 
Management 
Clinic 
 
Research 
 
 
Innovation 
 
 
Clinic 
 
Clinic 
Kathi Sørvig  
 
Anne Catrine Trægde 
Martinsen  
 
Sveinung Tornås  
 
 
Birgitte Dahl 
 
Christine Mol Slettenes 
Clinic manager and project owner.  
 
Research director. 
 
 
Manager of the Innovation department 
 
Manager of the RSM department 
 
Manager of the MNB department 
Project-group 
(co-authors) 
Research  
 
Innovation 
Clinic 
Clinic 
Unit of skills 
MNB  
 
 
RMS 
Ingebjørg Irgens 
 
Lene Mosberg 
Tina Kopseng 
Anne Birgitte Flaaten 
Gro Marianne Eriksen 
 
Hanne Karlstrøm-Bjørnstad (RN) 
Anne Innerdal (NA) 
Jeanine Paulsbo (RN) 
Sarah Amey Pedersen (NA) 
Project leader, guide in the data 
collection, analysis, report/article, 
Testbed coordinator 
Pressure measurement 
Pressure measurement 
Overall project nurse 
 
 
 
Project nurses in the departments 
 
 
 

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Reference 
group 
Consumer 
association  
 
 
 
 
Peer-consultant 
 
RMS 
 
 
Tidewave 
 
LARS; 
Morten Lind  
Sonja Brinsky 
 
 
 
Gunhild Bottolfsen 
 
Philip Bilberg 
 
 
Nina Fagerheim Åmodt  
Bjørn Sebastian Lorentzen 
 
Inputs related to development of the 
protocol, interview guide  
Communicate status and 
decisions/recommendations, bilaterally. 
                                                
Forthcoming input, and participation in 
the feasibility test 
Follow-up in the departments. 
 
 
Representatives from Tidewave 
Dissemination 
The results will be presented in the form of a report, as well as presented in national, and 
international professional meetings/conferences. An article will be submitted to peer-
reviewed, international journals.  
References 
1. Zena Moore, Barry Moore, Declan Patton: Systematic Review on the Role of Repositioning in the 
Prevention of Pressure Ulcers. RCSI School of nursing and midwifery, July 2018. 
2. Pressure Imaging Test – manual repositioning versus the Tidewave mattress. NORCE 2018/2019. 
Norwegian Reseach Centre. 
3. Sunnaas Rehabilitation hospital, 2019. https://sunhf.fisp.no/temasider/Sider/LISSY-styringsverktøy.aspx. 
4. Bjørlo K, Ribu L. Pilotstudie av trykksårprevalens I et norsk sykehus. Sykepleien Forskning 2009; 4(4): 
299- 305. 
5. Bjoro K. Clinical nursing-pressure sores in 33 000 hospital-patients. Interview by Kjell Arne Bakke. 
Tidsskrift Sykepleien, 1997; May 6;85(8): 10-17. 
6. Vanderwee K. Pressure ulcer prevalence in Europe: a pilot study. Journal of evaluation in clinical practice 
2007; 13 (2):227. 
7. Hagen EM, Eide GE , Rekand T, Gilhus NE, Gronning M. A 50-year follow-up of the incidence of 
traumatic cord injuries in Western Norway. Spinal Cord 2010: 48: 313-318. 
8. Lidal IB, Snekkevik H, Aamodt G, Hjeltnes N, Biering-Sørensen F, Stanghelle K. Mortality after spinal 
cord injury in Norway. J Rehabil Med 2007; 39: 145-151. 
9. Hoff JM, Bjerke LW, Gravem PE, Hagen EM, Rekand T. Pressure ulcers after spinal cord injury. Tidsskr 
Nor Legeforen 2012; 132: 838-839. 

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10. Dejong G, Tian W, Hsueh CH, Junn C, Karam C, Ballard PH, Smout RJ, Horn SD, Zanca JM, Heinemann 
AW, Hammond FM, Backus D. Rehospitalization in the first year after traumtic spinal cord injury after 
discharge from medical rehabilitation Arch Ohys Med Rehabil 2013; 94: S87-97. 
11. EPUAP. European pressure ulcer advisory panel: https://guidelinesales.com/ Downloaded December 13th 
2020. 
12. Grefen A. The biomechanics of sitting-acquired pressure ulcers in patients with spinal cord injury or lesions. 
Int Wound J. 2007 Sep;4(3):222-31. doi: 10.1111/j.1742-481X.2007.00330.x. 
13. Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: Psychometric Indicators to 
Detect Insomnia Cases and Evaluate Treatment Response. SLEEP, Vol. 34, No. 5, 2011, pp 601-608. 
14. Xsensor mat. URL; https://www.xsensor.com/solutions-and-platform/csm/continuous-skin-monitoring. 
Downloaded October 25th 2021.  
15. Huang C, Yuxia Ma Y, Wang C, Jiang M, Foon LY, Lv L, Han L. Predictive validity of the braden scale for 
pressure injury risk assessment in adults: A systematic review and meta- analysis. Nursing Open. 
2021;8:2194-2207.URL; https://onlinelibrary.wiley.com/doi/epdf/10.1002/nop2.792. Downloaded October 
25th 2021. 
16. EPUAP/NPIAP/PPPIA. Prevention and treatment of pressure ulcers/injuries: Clinical practice guideline. 
The international guideline, 2019. 
17. Charlifue S, Post MW, Biering-Sørensen F, Catz A, Dijkers M, Geyh S, Horsewell J, NoonanV, Noreau 
L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 
Sep;50(9):672-5. https://doi: 10.1038/sc.2012.27. 
18. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for 
insomnia research. Sleep Medicine 2 (2001);297-307 
19. Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the Brief Pain Inventory for 
Use in Documenting the Outcomes of Patients With Noncancer Pain. The Clinical Journal of Pain: 
September/October 2004 - Volume 20 - Issue 5 - p 309-318. 
20. eHelse: https://www.ehelse.no/personvern-og-informasjonssikkerhet/relevante-lover-og-forskrifter. 
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