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临床试验/CTRI/2024/09/073902
CTRI/2024/09/073902尚未招募不适用

Effect of post-surgical nurse-led follow-ups on pain intensity and activities of daily living among patients with knee replacement: A quasi-experimental study

NON SPONSORED1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年9月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
• To assess and compare the effectiveness of nurse-led follow-ups on pain intensity among the patients with knee replacement.

研究概览

简要总结

Post knee replacement complication and pain can be decrease by health education and regular follow up of the patient. These changes can be applied more effectively if the patient actively involve in the process.

Therefor additional nurse led follow ups in addition to standard treatment on the day before discharge of patients with knee replacement  in india could be used as an intensive approch to reduce the complication and pain.

STEP 1: Enrollment

Patients with Knee Replacement (TKR) and admitted to AIIMS Jodhpur will be enrolled in the study. Written consent will be obtained from each patient, ensuring that they are fully informed about the study’s purpose. Patients will also be briefed on the necessary follow-up procedures.

STEP 2: Baseline Data collection

The baseline data will be collected from the enrolled patients which will include the socio-demographic variables such as age, gender, height, weight, BMI, education, occupation, comorbidities, surgical history and type of surgery.

STEP 3: Non-random allocation of participants to both groups

 Initially patients, with Knee Replacement (TKR) with all the inclusion criteria will be assigned to the control group, and baseline data will be collected thereafter patients will be assigned inexperimental group and intervention will be provided to experimental group after collecting baseline data.STEP 4: Intervention

Participants in the control group will undergo the standard treatment protocol provided by the orthopedic department.

Participants in the experimental group will receive additional nurse-led follow-ups, in addition to the standard treatment, on the day before discharge.

Nurse led follow-ups will include: A animated video of approximate 10min. to 12min. will be used to deliver extensive education, offer guidance and reinforce key points after baseline data collection.

Telephonic reinforcement will be done for ensuring the compliance of interventions taught to patients during video-based education.

The video will contain following components-

·       Self-care (bathing, toileting and weight management)

·       Sitting time and position

·       Use of ambulatory aids and supportive device

·       Exercise follow up

·       Medication and supplement

STEP 5: Data collection

The Numerical Pain Rating Scale (NPRS) and Katz index of independence in activities of daily living scale will be administered on both control and experimental group to assess pain intensity and activities of daily living on first follow up at 2 weeks, second follow up at 4weeks and third follow up at 6week. Interview method will be used for data collection.

STEP 6: Data analysis

Thereafter, collected data will be coded and entered in master sheet for analysis.

PLAN FOR DATA ANALYSIS

Statistical analysis will be performed using statistical package for social sciences programme (SPSS).  Quantitative data analysis will be done with the help of descriptive statistics i.e., mean, percentage, frequency and standard deviation.Inferential statistics will be used to assess the research hypothesis and effectiveness of nurse-led follow up on knee replacement patients.

The level of significance will be set as p<0.05.

Data analysis plan:

Statistical analysis will be performed using statistical package for social sciences programme (SPSS).

Quantitative data analysis will be done with the help of descriptive statistics i.e., mean, percentage, frequency and standard deviation.

Inferential statistics will be used to assess the research hypothesis and effectiveness of nurse-led follow up on knee replacement patients.

The level of significance will be set as p<0.05.

Duration of study

The study will be completed in the duration of 6 month.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients who are willing to participate.
  • Post-operative knee replacement (unilateral or bilateral) patients admitted to orthopedic unit at AIIMS Jodhpur.
  • Patients above 18 years of age.
  • Patients are able to understand Hindi language.

排除标准

  • The patients with the known cases of major psychiatric illness or neurological problems.

结局指标

主要结局

• To assess and compare the effectiveness of nurse-led follow-ups on pain intensity among the patients with knee replacement.

时间窗: 2 weeks, 4 weeks , 6weeks.

• To assess and compare the effectiveness of nurse-led follow-ups on activities of daily living among the patients with knee replacement.

时间窗: 2 weeks, 4 weeks , 6weeks.

次要结局

  • • To determine association of pain with selected demographical variables among patients with knee replacement.(• To determine association of activity of daily living with selected demographical variables among patients with knee replacement.)

研究者

发起方
NON SPONSORED
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Megha chaudhary

AIIMS JODHPUR

研究点 (1)

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