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临床试验/CTRI/2024/02/062292
CTRI/2024/02/062292尚未招募3 期

Effect of nurse led educational interventions on prevention of post-operative complication and functional outcome among patients planned to undergo TURP : A Quasi experimental study.

Non sponsored2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Functional outcome that will be assessed by IIEF and IPSS

研究概览

简要总结

Post -operative complications can be decreased by health education and  improve functional  outcomes after TURP. These changes can be applied more effectively if the patient actively involves in the process.

therefore a nurse -led intervention education after TURP In India could be used as an intensive approach to reduce the complications and improve the functional outcomes.

STEP 1: Enrollment

The patients planned to undergo TURP from Urology IPD will be recruited and informed written consent will be obtained from the patients for conducting the study, and the patients will be informed about the follow-up check-up requirement.

STEP 2: Baseline Data collection

The baseline data will be collected from the enrolled patients which will include the Sociodemographic Variables (Age, Education, Occupation, Religion, Marital status and Area of residence), Clinical Variables (This part comprised; BPH signs and symptoms, medical diagnosis, associated comorbidities, and length of hospital stay. This part represented the baseline of the patient’s characteristics and their medical conditions and postoperative complications included hemorrhage, urinary tract infections, urinary retention, weak urinary stream and urinary incontinence.

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

Initially enrolled planned to undergo TURP will be assigned to Control group and then after the completion of baseline data collection and informing about follow-up requirement to control group, consecutive TURP Patients will be assigned to experimental group.

STEP 4: Intervention

Control group participants will receive the standard routine care to undergo TURP as per Urology IPD.

Experimental group participants will receive following intervention along with the standard routine care to undergo TURP:

Part 1 – Health Education: The Experimental group will be provided with health education about self-management strategies (for example avoid strenuous activity, such as heavy lifting, for four to six weeks or move any heavy object or avoid sexual activity for last four to six week , drinking plenty of water .  ) specific changes in behavior (such as bladder retraining i.e., pelvic floor exercises, double voiding, and urethral milking) and avoidance of constipation with dietary changes.

PART 2- Pamphlet distribution: Education pamphlet along with a compliance sheet will be provide to the experimental group patients immediately after health education. The pamphlet will include following components definition, benefit of procedure, and possible post-operative complication, all self-management strategies and specific changes in behavior explained above and expected future complication.

Part 3 – Telephone follow-up: Telephonically confirmation and reinforcement will be done once weekly for ensuring the compliance of interventions taught to the patient during Nurse led education (will also be reminded to maintain and regularly fill the compliance sheet).

STEP 5: Post-intervention data collection

After 12 weeks post-intervention, post-operative complications will be assess in control and experimental group. Questionnaires (IPSS, IIEF,) will be administered on both control and experimental group by direct face to face interview. Self-report and interview method will be used for collecting data.

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). Descriptive and inferential analysis will be done.

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

Pilot study: A try out will be conducted on ten percent of the study sample in a selected setting to evaluate the applicability & clarity of the tools.

 DURATION OF STUDY

The study will be completed in a period of 1 year.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • Patients above 40 years of age.
  • Patients who will be willing to give consent and time of data collection in the study.
  • Patients who can understand Hindi or English.

排除标准

  • Patients, who will not be able to receive, understand or respond to instructions.
  • Patients who had an open prostatectomy, A patient who had unsuccessful TURP.

结局指标

主要结局

Functional outcome that will be assessed by IIEF and IPSS

时间窗: IPSS in 1 month and IIEF in 3 months

次要结局

  • Post-operative complications(1 month)

研究者

发起方
Non sponsored
申办方类型
Other []

研究点 (2)

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