Cancer-Related PainNCT04436705
The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain
A study testing Progressive Muscle Relaxation (PMR) technique in people with Cancer-Related Pain, run by University of Jordan.
Trial summary
This randomized controlled trial was designed to evaluate the effectiveness of the Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in patients receiving palliative care in Jordan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-Related Pain
- What is being tested?
- Progressive Muscle Relaxation (PMR) technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age of 18 years and older
- diagnosed with cancer.
- reported complaints of pain ≥1 on a 0-10 Numerical Rating Scale (NRS) in the 24 hours before recruitment.
- were treated with non-opioid or weak opioid analgesic.
- had a Karnofsky Performance Scale Index ≥ 20.
- had regular access to a telephone.
Who cannot join
- a diagnosis of psychiatric illness, central nervous system tumors and musculoskeletal disorders (because these conditions may limit the effectiveness of PMR technique).
- using any type of complementary therapy during the trial period.
- Patients who had no pain and were treated with strong opioid analgesics.
About this study
Official title: The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain Among Palliative Care Patients: A Randomized Controlled Trial
This randomized controlled trial was designed to evaluate the effectiveness of the Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in patients receiving palliative care in Jordan.
The main hypothesis (H0) of this trial is that cancer patients receiving palliative care do not report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate. The sub-hypothesis (H1) of this trial is that cancer patients receiving palliative care report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate.
Read the detailed description
- Methods
- Design: This study was designed as an assessor-blinded, prospective, two parallel groups, randomized, controlled trial.
- Participants and setting: Participants were recruited from palliative care outpatient clinics at King Hussein Cancer Center in Amman, Jordan. The sample size was calculated using statistical software package G* Power 3.0.10. Based on α = 0.05, a power of 80%, and a medium effect size (Cohen's d = 0.50), the minimum required sample for each group was 64 patients. To be conservative and avoid the negative impact of attrition, the sample was increased to 150 patients for both groups; hence 75 participants were required per group.
- Randomization: The list of potential patients was given weekly to the first author by palliative nurse coordinator. The second author assessed the patients based on study inclusion criteria. A total of fifteen patients were excluded due to not meeting the trial criteria (n=13) and refusing to participate in the trial (n=2). The second author was not engaged in study intervention divided remaining 150 patients into two groups (intervention group (n=75), and control group (n=75)). Participants were randomly allocated in a 1:1 ratio to PMR and control groups using a computer-based minimization algorithm stratifying for gender, type of analgesics (non-opioid or weak opioid). The second author informed the participants about the results of randomization by providing labels coded either intervention or control group. Training on PMR technique were done by the first author who was not blinded to study groups. The participants were also not blinded to the study intervention due to the nature of kind of study intervention. All evaluations were completed by a single data collector who was blinded to study groups. In this trial, the blinding condition of data collector was maintained by two steps: (1) the first author informed the patients to not provide any information to the data collector about their allocated group, and (2) the data collector reminded all the patients to not reveal what group s/he was randomized to. Thus, the condition of assessor-blind was confirmed in this trial by blinding the data collector. During the study period, one participant in control group due to travel outside the country, and one participant in intervention group due to lack of sufficient time withdrew from the study. Thus, 148 participants completed the study (RMP group (n=74), and control group (n=74)).
- Procedures: The participants received training on the PMR intervention in the palliative care outpatient clinic in a quiet room with adequate light to make them feel relaxed during the intervention. Training on the PMR intervention was delivered individually by face to face. Patients in the intervention group were received instruction on PMR technique by the first author who trained and experienced in the technique. The theoretical session on the PMR took approximately 15 minutes. After the completion of the theoretical session, the first author demonstrated the PMR technique, then the participants applied the technique until they acquired the skill. Participants in intervention group received totally 30 to 40 minutes training on PMR technique including theoretical and practical sessions. Then, PMR booklets designed by the authors were given to the patients in training sessions. Furthermore, the first author recorded PMR technique with a voice recorder using her own voice, and the recorder file was downloaded on compact disc (CD). Each participant was given a copy of the CD to practice PMR technique at home. The intervention group continued the PMR daily for 20 minutes for a total of four weeks at their home. All participants were warned not to take analgesics either orally sixty minutes before or intravenously thirty minutes before the PMR technique. Daily reminder phone calls or Short Message Service (SMS) were performed to remind participants for practicing the technique and check their compliance with study protocol. Regarding to control group, the patients were invited to the same room and completed the baseline assessment. All participants received usual care for their pain during the study period which contained only pharmacological interventions. For ethical reasons, after completing this study, the participants in the control group had the opportunity to receive study intervention. These data were not analyzed.
- Data analysis:
Data were evaluated using Statistical Package for the Social Sciences (SPSS) version 22.0. Patients' demographics, clinical characteristics, and BPI scores were represented as mean values, standard deviations (SD), and percentages. Authors analyzed between-group differences at baseline using t tests for continuous variables and Chi-square tests for categorical variables. The comparisons between two groups in terms of BPI scores were made using Mann-Whitney U test. Additionally, Friedman test was conducted to assess the data for differences in BPI scores within-group. The level of significance was set at p < 0.05 for all tests.
- Conditions
- Cancer-Related Pain
- Being tested
- Progressive Muscle Relaxation (PMR) technique
- Keywords
- Cancer-related pain, Progressive Muscle Relaxation
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation (PMR) techniqueOther
The PMR technique utilized in this study was based on the original technique designed by Jacobson (1938) and subsequently modified by Bernstein and Borkovec (1973). The PMR technique involves tensing the individual muscle groups for about 5 seconds for each muscle. Then, allowing them to relax for about 10 seconds, and notice how the muscle feels when it is relaxed in contrast to how it felt when it was tensed. The technique is accompanied by breathing exercises in order to feel the sense of relaxation. In this study, the PMR technique refers to tensing and relaxing the muscles from the forehead to the feet one by one, including the eleven muscle groups (right arm, left arm, forehead, jaw and neck, back and shoulders, stomach, thighs, right calf, left calf, right foot and left foot). The total procedure takes around 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation (PMR) technique | Experimental | Participants in intervention group continued Progressive Muscle Relaxation (PMR) technique daily for 20 minutes for a total of four weeks addition to usual care. The usual care consists of pharmacological interventions to manage Cancer-related pain. Receives: Other: Progressive Muscle Relaxation (PMR) technique |
| control | No intervention | control group received only usual care for their pain during the study period. The usual care consists of pharmacological interventions to manage Cancer-related pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related pain
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
Measured: The BPI assessment was collected at baseline (T0) ( pre-intervention)
Cancer-related pain
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
Measured: The BPI assessment was collected at the end of PMR technique (4 weeks from T0)
Cancer-related pain
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
Measured: The BPI assessment was collected at 1-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startMay 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-Related 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Anshasi, University of Jordan
- Investigators
- Ministry of Health, Amman, Jordan, Study director, MOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436705
- Sponsor's protocol ID
- The University of Jordan
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anshasi H, Saleh M, Abdalrahim MS, Shamieh O. The effectiveness of progressive muscle relaxation technique in reducing cancer-related pain among palliative care patients: A randomized controlled trial. Br J Pain. 2023 Oct;17(5):501-509. doi: 10.1177/20494637231190191. Epub 2023 Jul 18.
PubMed 38107755
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain Among Palliative Care Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04436705
- Acronym / sponsor ID
- The University of Jordan
- Conditions
- Cancer-Related Pain
- Keywords
- Cancer-related pain, Progressive Muscle Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jun 2020 (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.
This randomized controlled trial was designed to evaluate the effectiveness of the Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in patients receiving palliative care in Jordan.
The main hypothesis (H0) of this trial is that cancer patients receiving palliative care do not report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate. The sub-hypothesis (H1) of this trial is that cancer patients receiving palliative care report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate.
Detailed description
- Methods
- Design: This study was designed as an assessor-blinded, prospective, two parallel groups, randomized, controlled trial.
- Participants and setting: Participants were recruited from palliative care outpatient clinics at King Hussein Cancer Center in Amman, Jordan. The sample size was calculated using statistical software package G* Power 3.0.10. Based on α = 0.05, a power of 80%, and a medium effect size (Cohen's d = 0.50), the minimum required sample for each group was 64 patients. To be conservative and avoid the negative impact of attrition, the sample was increased to 150 patients for both groups; hence 75 participants were required per group.
- Randomization: The list of potential patients was given weekly to the first author by palliative nurse coordinator. The second author assessed the patients based on study inclusion criteria. A total of fifteen patients were excluded due to not meeting the trial criteria (n=13) and refusing to participate in the trial (n=2). The second author was not engaged in study intervention divided remaining 150 patients into two groups (intervention group (n=75), and control group (n=75)). Participants were randomly allocated in a 1:1 ratio to PMR and control groups using a computer-based minimization algorithm stratifying for gender, type of analgesics (non-opioid or weak opioid). The second author informed the participants about the results of randomization by providing labels coded either intervention or control group. Training on PMR technique were done by the first author who was not blinded to study groups. The participants were also not blinded to the study intervention due to the nature of kind of study intervention. All evaluations were completed by a single data collector who was blinded to study groups. In this trial, the blinding condition of data collector was maintained by two steps: (1) the first author informed the patients to not provide any information to the data collector about their allocated group, and (2) the data collector reminded all the patients to not reveal what group s/he was randomized to. Thus, the condition of assessor-blind was confirmed in this trial by blinding the data collector. During the study period, one participant in control group due to travel outside the country, and one participant in intervention group due to lack of sufficient time withdrew from the study. Thus, 148 participants completed the study (RMP group (n=74), and control group (n=74)).
- Procedures: The participants received training on the PMR intervention in the palliative care outpatient clinic in a quiet room with adequate light to make them feel relaxed during the intervention. Training on the PMR intervention was delivered individually by face to face. Patients in the intervention group were received instruction on PMR technique by the first author who trained and experienced in the technique. The theoretical session on the PMR took approximately 15 minutes. After the completion of the theoretical session, the first author demonstrated the PMR technique, then the participants applied the technique until they acquired the skill. Participants in intervention group received totally 30 to 40 minutes training on PMR technique including theoretical and practical sessions. Then, PMR booklets designed by the authors were given to the patients in training sessions. Furthermore, the first author recorded PMR technique with a voice recorder using her own voice, and the recorder file was downloaded on compact disc (CD). Each participant was given a copy of the CD to practice PMR technique at home. The intervention group continued the PMR daily for 20 minutes for a total of four weeks at their home. All participants were warned not to take analgesics either orally sixty minutes before or intravenously thirty minutes before the PMR technique. Daily reminder phone calls or Short Message Service (SMS) were performed to remind participants for practicing the technique and check their compliance with study protocol. Regarding to control group, the patients were invited to the same room and completed the baseline assessment. All participants received usual care for their pain during the study period which contained only pharmacological interventions. For ethical reasons, after completing this study, the participants in the control group had the opportunity to receive study intervention. These data were not analyzed.
- Data analysis:
Data were evaluated using Statistical Package for the Social Sciences (SPSS) version 22.0. Patients' demographics, clinical characteristics, and BPI scores were represented as mean values, standard deviations (SD), and percentages. Authors analyzed between-group differences at baseline using t tests for continuous variables and Chi-square tests for categorical variables. The comparisons between two groups in terms of BPI scores were made using Mann-Whitney U test. Additionally, Friedman test was conducted to assess the data for differences in BPI scores within-group. The level of significance was set at p < 0.05 for all tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation (PMR) technique | Experimental | Other: Progressive Muscle Relaxation (PMR) techniqueParticipants in intervention group continued Progressive Muscle Relaxation (PMR) technique daily for 20 minutes for a total of four weeks addition to usual care. The usual care consists of pharmacological interventions to manage Cancer-related pain. |
| control | No intervention | –control group received only usual care for their pain during the study period. The usual care consists of pharmacological interventions to manage Cancer-related pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age of 18 years and older
- diagnosed with cancer.
- reported complaints of pain ≥1 on a 0-10 Numerical Rating Scale (NRS) in the 24 hours before recruitment.
- were treated with non-opioid or weak opioid analgesic.
- had a Karnofsky Performance Scale Index ≥ 20.
Key exclusion criteria (3 listed)
- a diagnosis of psychiatric illness, central nervous system tumors and musculoskeletal disorders (because these conditions may limit the effectiveness of PMR technique).
- using any type of complementary therapy during the trial period.
- Patients who had no pain and were treated with strong opioid analgesics.
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 |
|---|---|---|
| Progressive Muscle Relaxation (PMR) techniqueThe PMR technique utilized in this study was based on the original technique designed by Jacobson (1938) and subsequently modified by Bernstein and Borkovec (1973). The PMR technique involves tensing the individual muscle groups for about 5 seconds for each muscle. Then, allowing them to relax for about 10 seconds, and notice how the muscle feels when it is relaxed in contrast to how it felt when it was tensed. The technique is accompanied by breathing exercises in order to feel the sense of relaxation. In this study, the PMR technique refers to tensing and relaxing the muscles from the forehead to the feet one by one, including the eleven muscle groups (right arm, left arm, forehead, jaw and neck, back and shoulders, stomach, thighs, right calf, left calf, right foot and left foot). The total procedure takes around 20 minutes. | Other | Progressive Muscle Relaxation (PMR) technique |
Primary outcome
Cancer-related pain
Time frame: The BPI assessment was collected at baseline (T0) ( pre-intervention)
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
Cancer-related pain
Time frame: The BPI assessment was collected at the end of PMR technique (4 weeks from T0)
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
Cancer-related pain
Time frame: The BPI assessment was collected at 1-month follow-up (T2)
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 38107755Anshasi H, Saleh M, Abdalrahim MS, Shamieh O. The effectiveness of progressive muscle relaxation technique in reducing cancer-related pain among palliative care patients: A randomized controlled trial. Br J Pain. 2023 Oct;17(5):501-509. doi: 10.1177/20494637231190191. Epub 2023 Jul 18.
- 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. This study is not recruiting at the moment.
Ministry of Health, Amman, Jordan study director
MOH
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation (PMR) technique in people with Cancer-Related Pain, run by University of Jordan.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cancer-related pain (time frame: The BPI assessment was collected at baseline (T0) ( pre-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436705, which also lists 1 linked publication.
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 22 Jun 2020.