Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic pain that is not caused by cancer is a wide-spread health problem and one that is not well controlled. Nurses can play a vital role in pain management, using their specialist knowledge and adopting a holistic approach to help patients to best manage their pain. Improving the quality of life, reducing disability, accepting state of health, coping, and breaking the vicious circle of pain will be the areas that our care management programme will concentrate on. We want to look at to what extent a nurse-guided service is successful at managing patients chronic non-cancer pain and investigate its effects on a patients quality of life, the amount of pain killing drugs taken, the amount of pain felt and how depressed or anxious they feel. We also want to see if the treatment helps patients to cope with their condition and how satisfied they are with the programme.

Who can participate?
Patients registered with the chronic pain unit (part of the anaesthesiology service) at the Hospital Costa del Sol. These patients are referred for attention, from a medical specialist, due to the uncontrolled chronic pain suffered.

What does the study involve?
Initially, all participants are asked to fill in a series of questionnaires on health-related quality of life, feelings of depression and anxiety and the amount of pain they feel. A nurse assesses the patients current ability to manage and cope with their condition. They are all then randomly allocated into one of two groups. Those in group 1 (control group) receive the usual care given to the patients at the pain clinic. An anaesthetist gives each patient a clinical, psychological and social examination and makes a brief assessment based on questions about the pain suffered (its location, intensity, characteristics, onset and duration). Those in group 2 (the experimental group) receive the usual care and the new nursing care programme for people with chronic non-cancer pain. This programme consists of an individualised initial session, followed by six group sessions. Assessments based on questionnaires for participants in both groups are then performed at 12 and 24 weeks after the start of treatment.

What are the possible benefits and risks of participating?
The programme of a low-risk, psycho-educational nature. CALIDO-CR is a structured programme intended to equip participants with the tools needed to improve their quality of life in relation to the pain experienced, by making appropriate use of health services and improving accessibility via the liaison nurse at the pain treatment unit.

Where is the study run from?
The Hospital Costa del Sol. Marbella (Spain)

When is the study starting and how long is it expected to run for?
June 2014 to April 2016

Who is funding the study?
The Regional Health Ministry of Andalusia.(Spain).

Who is the main contact?
Angeles Morales-Fernandez

Trial website

Contact information



Primary contact

Miss Angeles Morales-Fernadez


Contact details

Autovía A-7 Km 187
+34 (0) 671 597 031

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Impact on quality of life of a nursing intervention programme for patients with chronic non-cancer pain: an open, randomised controlled parallel study



Study hypothesis

A nursing-guided, structured programme for persons with chronic non-cancer pain might substantially benefit their health-related quality of life, coping strategies, pharmacological management and state of mind

Ethics approval

CEI Costa del Sol, 28/10/2013, ref. 002_CS_0251

Study design

Open randomised parallel controlled study.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format


Chronic non-cancer pain


The control group will follow the usual procedure established for such patients at our pain treatment unit. An anaesthetist will ascertain the patient’s clinical background and conduct a clinical, psychological and social examination (at present, no clinimetric tool is used for this purpose, nor is any particular procedure established).

These patients will be addressed in parallel, with both usual care and the new nursing care programme for people with chronic non-cancer pain. This programme consists of an individualised initial session, followed by six group sessions. At 12 and 24 weeks after the start of treatment, telephone follow up contact will be made and the clinimetric tools again applied. The experimental group will take part in six group therapy sessions led by nurses, aimed at the acquisition of tools for the self-management of pain. a holistic approach in which the patient plays a proactive role in addressing the disease process. Improving the quality of life, reducing disability, achieving acceptance of health status, coping, and breaking the vicious circle of pain should be the prime objectives of our care management programme.

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Level of health-related quality of life (SF -36) v1
2. Level of pain (VAS)

All measured at baseline, at 12 weeks and 24 weeks

Secondary outcome measures

1. Coping policy (Nurses’ clinical judgment / NOC 1302)
2. Level of anxiety (GAD 7)
3. Level of depression (PHQ 9)
4. Level of satisfaction

All measured at baseline, at 12 weeks and 24 weeks, other than measure 4, which is measured only at the end of the study

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Patients aged 18-70 years
2. Knowledge and understanding of Spanish language
3. Patients voluntarily agree to participate in the programme and give their signed informed consent

Participant type


Age group




Target number of participants

138 subjects in each study arm (276 in total). Total n = 318 subjects.

Participant exclusion criteria

1. Patients with psychiatric pathology and/or cognitive deterioration (in case of doubt, determined by a brief examination of mental state)
2. Patients with a cancer
3. Patients with a terminal pathology
4. Patients pending the resolution of legal processes related to accidents, occupational incapacity and/or recognition of incapacity

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Autovía A-7 Km 187

Sponsor information


Regional Health Ministry of Andalusia (Spain)

Sponsor details

Avda. Américo Vespucio 5
Bloque 2
2°Planta Izq.
Parque Científico y Tecnológico Cartuja 93
+34 (0) 955 040 450

Sponsor type




Funder type


Funder name

Regional Health Ministry of Andalusia (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes