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The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain

Primary Purpose

Cancer-Related Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive Muscle Relaxation (PMR) technique
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer-Related Pain focused on measuring Cancer-related pain, Progressive Muscle Relaxation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Progressive Muscle Relaxation (PMR) technique

    control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2020
    Last Updated
    June 18, 2020
    Sponsor
    University of Jordan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04436705
    Brief Title
    The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain
    Official Title
    The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain Among Palliative Care Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Jordan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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
    2. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer-Related Pain
    Keywords
    Cancer-related pain, Progressive Muscle Relaxation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    148 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Progressive Muscle Relaxation (PMR) technique
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Progressive Muscle Relaxation (PMR) technique
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Cancer-related pain
    Description
    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).
    Time Frame
    The BPI assessment was collected at baseline (T0) ( pre-intervention)
    Title
    Cancer-related pain
    Description
    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).
    Time Frame
    The BPI assessment was collected at the end of PMR technique (4 weeks from T0)
    Title
    Cancer-related pain
    Description
    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).
    Time Frame
    The BPI assessment was collected at 1-month follow-up (T2)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ministry of Health, Amman, Jordan
    Organizational Affiliation
    MOH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain

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