NCT05148364

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

November 25, 2021

Last Update Submit

May 20, 2024

Conditions

Keywords

spiritualitylow back pain

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 weeks

  • Spirituality

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

    8 weeks

  • 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.

    8 weeks

Interventions

interviewBEHAVIORAL

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?

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Chang-hua, 500, Taiwan

RECRUITING

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • Liu LJ, Peng HL, Lin EM, Liang WP. Do We Ask What the Deities Can Do for Us? The Roles of Dao Religion and Resilience in Suicidality in Chronic Pain. Pain Res Manag. 2025 Apr 17;2025:3056383. doi: 10.1155/prm/3056383. eCollection 2025.

MeSH Terms

Conditions

Low Back Pain

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ling-Jun Liu, MSc

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 8, 2021

Study Start

July 20, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations