跳至主要内容
临床试验/CTRI/2024/09/073280
CTRI/2024/09/073280招募中不适用

Effectiveness of a co-designed workplace based intervention on pain, muscle dysfunction, and quality of life among Radiographers

Ullas U Nayak1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年9月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
112
试验地点
1
主要终点
Pain: Numeric Rating Scale (NPRS) and Algometer for pressure pain threshold.

研究概览

简要总结

Phase 1: Permission will be obtained from institutional ethics committee to conduct cross-sectional study to determine factors affecting work related musculoskeletal disorders among Radiographers. Sample size is 200. Based on the inclusion/ exclusion criteria participants will be enrolled. An informed consent will be taken. A questionnaire will be administered by researcher which will take 15-20 mins using Google Forms. Participants will be approached through the email ids received from hospital authorities, and social media contacts. Sample size for this is 200.

Phase 2: Focus group discussion (FGD) will be conducted with Radiographers and experts. Discussion will be moderated by Researcher with Physiotherapy background who will be accompanied by an assistant moderator a Phd Scholar from DBMS at Department of Basic Medical Sciences, MAHE. Focus group discussion will utilize a semi-structured interview guide with open-ended questions to explore needs and challenges at work practices,strategies obtained to prevent and manage WMSD and preferences for intervention components (e.g. exercise, education, information material, video clip, equipment adjustments).These FGD will last for 30-45 minutes, post FGD refreshments will be provided. Minimum of 2 FGD will be conducted and will be conducted till the point of saturation. The session will be audiotaped and transcribed.Thematic analysis will be done to identify key themes using inductive and deductive coding, insights, and suggestions from participants.

Delphi method: The focus group findings will be shared with experts and stakeholders using Delphi method.10 participants- Physiotherapist with background of Occupational health, Radiographer, Ergonomists, Clinical Psychologists, and Hospital administrators. Academicians and researchers with relevant expertise will be eligible.

Round 1: Experts and stakeholders will be asked to suggest intervention components based on the end-user needs and preferences and provide feedback on the feasibility, effectiveness, and sustainability of proposed components.

Expert and stakeholder suggestions will be summarized and categorized.

Round 2: The revised list of intervention components incorporating expert feedback from Round 1 will be shared with experts and stakeholders and will be asked to rate the importance and feasibility of each component on a 3 point Likert scale and provide further comments and suggestions for refinement.

Rounds will be repeated if necessary until 75 % of consensus is reached on the key components of the intervention program.

Phase 3: A cluster randomized trial will be conducted across 16 hospitals. The hospitals will be randomized to either the intervention or control group. Single stage- Cluster Randomised Controlled Trial using Computer generated random number table.

For all the 16 hospitals permission will be sought. If the hospital authority specifies the need for Ethics committee approval from their hospital or associated institution, then IEC approval will be taken. Hospitals without an Ethics committee will be covered under the Institution Ethics Committee under Kasturba Hospital since these all are within 60kms of perimeter from Kasturba Hospital.

Based on inclusion-exclusion criteria and informed consent will be obtained from 112 interested participants. Participants will be recruited from hospitals at their worksite. Individuals will be approached face-to-face for taking consent following which they will be recruited and there will be no travelling involved. The intervention group will receive an intervention program and control will continue with their usual daily activity. The intervention program will be implemented for eight weeks and will include a minimum of two supervised sessions. Outcome measures will be used to assess the program’s effectiveness for Pain-Numeric Rating Scale (NPRS) and Algometer for pressure pain threshold, Muscle strength- Hand-held dynamometer for upper limb (shoulder flexors, abductors, elbow flexors) and lower limb (hip flexors, extensors, abductors, knee extensors), and Jamar dynamometer for grip strength, Bioelectrical impedance analyzer (BIA), Workplace Activity Limitations Scale, Work Ability Index, Work-Related Quality of Life Scale-2 (WRQoL-2). Data will be collected at baseline and again ten weeks after the intervention.

If the intervention is effective, same intervention will be given to control group.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 56.00 Year(s)(—)
性别
All

入选标准

  • Radiographers with Work-related musculoskeletal disorder with NPRS score ≥
  • Radiographers appointed as full-time employees
  • With more than one year of experience
  • Who pass the Physical Activity Readiness Questionnaire (PAR-Q).

排除标准

  • Supervisors, students, and managers working in Radiography departments.
  • Radiographers who have any history of trauma, generalised inflammatory diseases or degenerative diseases or diagnosed neoplastic conditions or any active infection.

结局指标

主要结局

Pain: Numeric Rating Scale (NPRS) and Algometer for pressure pain threshold.

时间窗: Baseline and 8 weeks

Body composition: Bioelectrical impedance analyzer (BIA).

时间窗: Baseline and 8 weeks

Activities: Workplace Activity Limitations Scale.

时间窗: Baseline and 8 weeks

Participation: Work Ability Index.

时间窗: Baseline and 8 weeks

Quality of life: Work-Related Quality of Life Scale-2 (WRQoL-2).

时间窗: Baseline and 8 weeks

次要结局

  • Analgesic use and any therapy taken: Self-reported.(Muscle strength: Hand-held dynamometer for upper limb (shoulder flexors, abductors, elbow flexors) and lower limb (hip flexors, extensors, abductors, knee extensors), and Jamar dynamometer for grip strength.)

研究者

发起方
Ullas U Nayak
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

ULLAS U NAYAK

Manipal Academy of Higher Education

研究点 (1)

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