The Effectiveness of Client-Centered Intervention on Quality of Life and Perceived Occupational Performance and Satisfaction After Total Hip Arthroplasty-A Single Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Nottingham Health Profile
研究概览
简要总结
The current study was conducted to effectiveness of the Client-centered (CC) intervention after Total Hip Arthroplasty (TKA). The current study was planned to examine the impact of the CC intervention on quality of life, perceived occupational performance and satisfaction. The current study was designed according to the CONSORT statement, which provides a standardized method for randomized controlled trial (RCT) design. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.
详细描述
This study was designed to examine the effectiveness of 6-week CC intervention on quality of life and perceived occupational performance and satisfaction level in individuals aged 65 and over after THA. The study has a randomized controlled structure planned according to the CONSORT Statement. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.
Participants To determine the number of samples, a power analysis, detailed in the statistical analysis section, was performed and it was determined that there should be at least 16 participants for each group. The study evaluated 41 older adults, considering the inclusion and exclusion criteria, as well as predicting participants who would drop out of the study for any reason during the intervention process. These 41 participants who were admitted to a public university's occupational therapy department between July 2022 and July 2023 were screened.
According to the inclusion and exclusion criteria, one participant from each group was excluded from the study because they participated in another rehabilitation program. The remaining 39 participants were randomly assigned to either the CC group or the control group using a computer-generated randomization technique. Initial evaluations were made of the participants, who were divided into 20 participants in the CC group and 19 participants in the control group. Afterwards, during the intervention process, 2 participants from the CC group and 1 from the control group were excluded from the study because they could not participate regularly.
Measurement The demographic characteristics of the participants were recorded, including age, sex, education level, body mass index, smoking/alcohol use, operation region. On the other hand, the following scales were used for all participants, both for use in the inclusion criteria and to measure quality of life and perceived occupational performance and satisfaction.
The scale used in the inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Being 65 years of age or older,
- •(2) Mini Mental State Examination score of ≥ 24,
- •(3) having undergone unilateral total hip replacement,
- •(4) education level of at least completion of elementary school,
- •(5) ability to understand and follow verbal instructions,
- •(6) volunteer to participate in the study
排除标准
- •(1) revision surgery,
- •(2) having any chronic disease that will affect the rehabilitation process,
- •(3) auditory and visual problems that may affect rehabilitation implementation and communication,
- •(4) postoperative complications (e.g. nerve injury and deep vein thrombosis), and
- •(5) attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) before and during the study period
结局指标
主要结局
Nottingham Health Profile
时间窗: 10 minutes
Nottingham Health Profile Nottingham Health Profile (NHP) is a 38-item quality of life survey that measures individuals' perceived health problems and the extent to which these health problems affect ADLs. It consists of 6 sub-dimensions and each sub-dimension consists of 0-100 points (0 points indicate good health status-100 points indicate poor health status): energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). The Turkish version of the NHP was used to evaluate the health-related quality of life.
Canadian Occupational Performance Measure
时间窗: 40 minutes
The Canadian Occupational Performance Measure (COPM) was used to identify occupations where participants had problems with ADLs and to determine the perceived occupational performance and satisfaction level in these occupations. In the COPM, which was designed with the semi-structured interview method, firstly, the occupations in which the participants experience problems in the areas of self-care, productivity and free time are determined by giving importance points with a 1-10 Likert type scoring system. The higher the score, the higher the performance and satisfaction level.
次要结局
未报告次要终点
研究者
Berkan Torpil, PhD
Associate Professor
Saglik Bilimleri Universitesi