NCT04878900

Brief Summary

The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. In this cross-sectional study, 100 volunteer patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain were included. Age, gender, body-mass index (BMI) and systemic diseases of the participants were recorded as demographic data. Data were collected regarding the area of the body where pain is most dominant in the musculoskeletal system and how long the pain has been in these area, whether there is routine use of analgesics before and after the pandemic and the amount if any, whether the person or the person's relatives have a history of COVID-19, whether exercising regularly before and after the pandemic. Afterwards, the participants were asked to evaluate their general pain severity and global well-being assesment with the visual analog scale (VAS) in the pre-pandemic period and in the last month. For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad. The distance between the point marked by the patient and the starting point was measured. The higher the measured value meant the greater the severity of the patient's pain and the worse the patient's global assessment \[11\]. Subsequently, the patients were asked to answer questions on the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI) and Nottingham Health Profile (NHP) scales.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 4, 2021

Last Update Submit

May 4, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • General pain severity and global well-being assesment with the visual analog scale (VAS).

    For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad.

    2 months

  • Perceived Stress Scale (PSS)

    It is a scale to evaluate how stressful some situations in life are perceived by the individual. The long form of the scale consists of 14 items in total. The situations given in each item are evaluated with a 5-point Likert-type scale (0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often). The scale has two short forms consisting of 10 and 4 items. The total score ranges from 0-56 for PSS-14, 0-40 for PSS-10, and 0-16 for PSS-4. The higher the scores, the greater the person's perception of stress.

    2 months

  • Pittsburgh Sleep Quality Index (PSQI)

    It is a scale to evaluate sleep quality and disorders. It consists of 24 questions in total. 19 questions are self-assessment questions, 5 questions are assessment questions made by their spouse or roommate. 18 question items are used in scoring. The scale consists of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. While some of the components consist of a single question item, some are formed by grouping several items. Each component is scored between 0 and 3 points, and the total score of the components gives the total score of the scale. The higher the total score the worse the sleep quality.

    2 months

  • Nottingham Health Profile (NHP)

    It is a general health status scale that evaluates perceived problems in physical, emotional and social areas and how these problems affect daily activities. The questions in the first part of the scale are about the health status of the people, and the questions in the second part are about the effects of their health status on daily life. The first part consists of 38 items in which each item is answered as yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation and physical mobility and energy. The higher the score, the worse the perception of quality of life regarding health status. The second part consists of 7 items that question whether there are problems in the daily life areas that are most likely to be affected by the health condition of the person, such as work life, housework, social life, interpersonal relationships, sexual life, hobbies and holidays, each item being answered as yes or no.

    2 months

Interventions

SurveyOTHER

Survey

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain

You may qualify if:

  • Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain

You may not qualify if:

  • Having a history of trauma and surgical intervention in the last 3 months,
  • Having a history of known inflammatory rheumatic disease,
  • Having a history of chronic severe systemic or neurological disease,
  • Having a moderate or severe impairment of cognitive status determined by the minimental test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainCOVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 10, 2021

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations