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RecruitingNCT05148364Updated May 21, 2024

Pain Resilience and Spiritual Health in Low Back Pain

An observational study in Low Back Pain, sponsored by Changhua Christian Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Changhua Christian Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
20 Years to 100 Years
Sex
All
01

Study summary

In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the patient including the body, mind, and family. Pain resilience of chronic pain patients' has been found to be a different construct from the general resilience in the field of chronic diseases. Pain resilience emphasizes the cognitive/emotional positivity and behavior persistence of pain patients' when facing pain. So far, there has been no research on the theme of "pain resilience and spiritual health". Researchers have seen the necessity of care and assistance for patients with chronic low back pain. Hence, this study would like to explore "how pain resilience and spiritual health affect the pain experience of patients with chronic low back pain ".

Research objectives: 1. To understand how spiritual health and pain resilience interact to influence the the pain experience in patients with chronic low back pain and 2. To understand how spiritual health and pain resilience interact and influence they way how patients with chronic low back pain cope with pain.

Method: This research plan will be implemented upon obtaining the approval from IRB. An estimated 15 cases will be enrolled. Through in-depth interviews and collection of observational data during interviews, the interviewer will record, transcribe and analyze the narratives and experience descriptions.

The results of this study can become an important basis for clinical care of patients with chronic low back pain.

Read the detailed description

In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the patient including the body, mind, and family. Pain resilience of chronic pain patients' has been found to be a different construct from the general resilience in the field of chronic diseases. Pain resilience emphasizes the cognitive/emotional positivity and behavior persistence of pain patients' when facing pain. So far, there has been no research on the theme of "pain resilience and spiritual health". Researchers have seen the necessity of care and assistance for patients with chronic low back pain. Hence, this study would like to explore "how pain resilience and spiritual health affect the pain experience of patients with chronic low back pain ".

Research objectives: 1. To understand how spiritual health and pain resilience interact to influence the the pain experience in patients with chronic low back pain and 2. To understand how spiritual health and pain resilience interact and influence they way how patients with chronic low back pain cope with pain.

Method: This research plan will be implemented upon obtaining the approval from IRB. An estimated 15 cases will be enrolled. Through in-depth interviews and collection of observational data during interviews, the interviewer will record, transcribe and analyze the narratives and experience descriptions.

A spiritual consultant and a psychologist will interview the participants about their experiences of chronic low back pain, how they interpret their pain experience and how they cope with the persistent pain. Each participant will be interviewed individually.

Questions related to the following three aspects will be asked:

  1. Attributes: describe the changes in your personality, mood, and general happiness you have observed after you starting having chronic low back pain.
  2. Pain resilience: How would you describe this persisting pain experience? How do you arrange your daily activity? What do you do to deal with this persistent pain?
  3. Spirituality: As a person with chronic low back pain, how do you interpret this pain experience? Do you seek connections with higher powers (such as powers from religion) when you are desperate because of pain? Since the pain is chronic and persistent, it might not go away, how would you define your life?

Plan of analysis: The current study will adopt interpretative phenomenological analysis to to examine the pain experience of the participants. After data was collected through interview, transcripts will be coded in detail. In the process of analyzing the text, the investigators will categorize the text into themes.

The results of this study can become an important basis for clinical care of patients with chronic low back pain.

02

Conditions studied

  • Low Back Pain

Keywords

  • spirituality
  • low back pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 15 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Changhua Christian Hospital is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants should have persistent low back pain that has lasted for at least three months. Pain is a very subjective experience, so it is not necessary that the participant has to be diagnosed by a physician.

Inclusion criteria

  • Individual with non-malignant persistent low back pain that has lasted for at least three months.
  • Individual that is willing to undergo interview about their pain experience.
  • Individual ages between 20 and 100.

Exclusion criteria

Exclusion Criteria:

  • Individual with cognitive or psychological impairments that may compromise the ability to understand the interviewing questionnaire.
  • Individual younger that 20 years old.
  • The pain is clearly related to spinal cancer.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Interventions

  • Behavioralinterview

    A spiritual consultant and a psychologist will interview the participants about their experiences of chronic low back pain, how they interpret their pain experience and how they cope with the persistent pain. Each participant will be interviewed individually. Questions related to the following three aspects will be asked: 1. Attributes: describe the changes in your personality, mood, and general happiness you have observed after you starting having chronic low back pain. 2. Pain resilience: How would you describe this persisting pain experience? How do you arrange your daily activity? What do you do to deal with this persistent pain? 3. Spirituality: As a person with chronic low back pain, how do you interpret this pain experience? Do you seek connections with higher powers (such as powers from religion) when you are desperate because of pain? Since the pain is chronic and persistent, it might not go away, how would you define your life?

06

What researchers measure

Primary outcomes

  1. Pain resilience scale (PRS)

    A 14-item scale used to measure the level of pain resilience. Participant could choose from 0 to 4 on each item to indicate how much one agrees to the statement used to describe one's reaction under persisting pain. "0" indicates "strongly disagree" while "4" indicates "fully agree". Higher total score on the PRS indicates higher resilience to pain.

    Time frame: 8 weeks

  2. Spirituality

    Participant gives a simple yes/no answer as to whether the participant has a religion or participate in religious activities.

    Time frame: 8 weeks

  3. Patient Health Questionnaire-9

    Patient Health Questionnaire-9 is a 9-item scale used to measure the level of depression in a respondent. Participant chooses from 0 to 3 on each item to indicate the frequency of experiencing each listed symptoms that might be part of depression. Higher total score indicates higher level of depression.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Changhua Christian Hospital
    Chang Hua, 500, Taiwan
    Recruiting
08

References and documents

Publications

  • Slepian PM, Ankawi B, Himawan LK, France CR. Development and Initial Validation of the Pain Resilience Scale. J Pain. 2016 Apr;17(4):462-72. doi: 10.1016/j.jpain.2015.12.010. Epub 2015 Dec 31. PubMed 26748044 ↗
  • Ankawi B, Slepian PM, Himawan LK, France CR. Validation of the Pain Resilience Scale in a Chronic Pain Sample. J Pain. 2017 Aug;18(8):984-993. doi: 10.1016/j.jpain.2017.03.013. Epub 2017 Apr 18. PubMed 28428092 ↗
  • Gonzalez CE, Okunbor JI, Parker R, Owens MA, White DM, Merlin JS, Goodin BR. Pain-Specific Resilience in People Living With HIV and Chronic Pain: Beneficial Associations With Coping Strategies and Catastrophizing. Front Psychol. 2019 Sep 6;10:2046. doi: 10.3389/fpsyg.2019.02046. eCollection 2019. PubMed 31555190 ↗

Individual participant data

Plan to share: Undecided — Personal identifiers will be removed before data sharing (if we decide to share the data). Currently, we prefer to share only the descriptive statistics of the demographic data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05148364
Lead sponsor
Changhua Christian Hospital
Responsible party
Sponsor
First posted
Dec 8, 2021
Start date
Jul 20, 2022
Primary completion
May 31, 2024 (estimated)
Completion
May 31, 2024 (estimated)
Last update
May 21, 2024

Study contacts

Ling-Jun Liu, MSc
Contact
lingjun.liu1203@gmail.com
+886-47238595 ext. 3236
Ling-Jun Liu, MSc
principal investigator · Changhua Christian Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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