Development of Perioperative Follow-up Protocols and Evaluation of Their Effectiveness for Women Aged 30-65 Having Pelvic Organ Prolapse Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Quality of Life Scale
研究概览
简要总结
The goal of this clinical trial is to develop perioperative follow-up and evaluation of their effectiveness protocols in women aged 30-65 having pelvic organ prolapse surgery.
The main questions it aims to answer are:
- Is the perioperative follow up protocol developed for women aged 30-65 having pelvic organ prolapse surgery effective?
- Does the developed perioperative follow up protocol for women aged 30-65 having pelvic organ prolapse surgery have an effect on quality of life, pelvic organ symptom score, sexual function, functional health patterns and anxiety?
详细描述
In order to maintain holistic care, maintaining communication with the individual after discharge and providing individual counseling regarding the problems experienced have an important place in patient follow-up. In this context, perioperative consultancy should be provided under nurse management to make it easier for patients to cope with physical and psychosocial problems, improve quality of life and ensure continuity of care. Therefore, in this research; the aim is to develop perioperative follow up protocols and evaluate their effectiveness for women aged 30-65 who have pelvic organ prolapse surgery.
The sample of the research; It is planned to consist of a total of 102 women, 51 in the Follow-up Group and 51 in the Control Group, who meet the inclusion criteria and voluntarily agreed to participate in the research (Calculated using G.Power 3.1.7 program). After informed consent is obtained, full randomization technique will be used to assign participants to follow-up and control groups. Full randomization will be done via the website http://www.randomizer.org/. Two computer-generated randomization sequences will be applied on a one-to-one basis.
During the pre-test and post-test data collection phase, it is planned to use the 'Descriptive Characteristics Form', 'Pelvic Organ Prolapse Quality of Life Scale', 'Pelvic Organ Symptom Score', 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Form', 'State-Trait Anxiety Inventory Short Version', and 'Functional Health Patterns Assessment Form' in the perioperative period.
After preoperative data is collected, the Follow-up Group will be shown a preoperative patient education video. In the postoperative period, Follow-up Group's data will be collected within 24-48 hours and the patient will be shown a postoperative education video before discharge. After discharge; at the 2nd, 6th, 10th and 14th weeks, Follow-up Group's will be followed up by phone and their data will be collected. In addition, a satisfaction form to evaluate the education videos will be applied to the Follow-up Group in the 14th week. The Control Group will not receive any intervention by the researcher and will receive routine perioperative care. Control Group's data will be collected in the preoperative and postoperative period. Additionally, Control Group's data will be collected by phone at the 2nd, 6th, 10th and 14th weeks after discharge and a postoperative education video will be watched after the data is collected at the 14th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being stage ≥2 according to POP Classification (POP-Q),
- •Being between 30-65 years old,
- •Being sexually active,
- •Ability to read and write,
- •Ability to speak Turkish,
- •Ability to use phone
- •Having a phone that can be reached at all times and
- •Agreeing to participate in the study
排除标准
- •Being stage <2 according to POP Classification (POP-Q),
- •Being between <30 and >65 years of age,
- •Not being sexually active,
- •Not being able to read and write,
- •Not being able to speak Turkish,
- •Inability to use the phone
- •Not having a phone that can be reached at all times and
- •Not agreeing to participate in the study
- •Discontinue the research for any reason
结局指标
主要结局
Quality of Life Scale
时间窗: Baseline and at 2, 6, 10 and 14 weeks postoperatively
Evaluation of the quality of life of women who had pelvic organ prolapse surgery before and after the study. The scale was developed to evaluate the general health perceptions of patients with pelvic organ prolapse, the symptoms experienced during prolapse, and the effects and consequences of symptoms on quality of life. The scale consists of eight areas. There is no total score for the areas used in the scale, each area is scored individually.In calculating the score of the areas; a four-point scoring system is used for the expressions; does not affect at all, slightly affects, moderately affects and greatly affects; 1, 2, 3, 4, respectively. Each area of the scale is calculated separately depending on the questions it contains. The scale is scored between 0 and 100. High scores obtained from the scale indicate that the quality of life is impaired, while low scores indicate that the quality of life is better.
Functional Health Patterns
时间窗: Baseline and at 24.-48hours and 2, 6, 10 and 14 weeks postoperatively.
Evaluation of the health patterns of women who had pelvic organ prolapse surgery before and after study. It was developed by researchers in line with the relevant literature according to Gordon's Functional Health Patterns. The form, which is created separately for the preoperative, postoperative and post-discharge periods, covers 11 areas such as health perception, nutrition, excretion, activity, sleep, cognitive-perception style. The preoperative, postoperative and post-discharge health status of the patients, the problems they experience and the complications that may develop are determined. The items in the form are evaluated with yes-no and 0-10 (0 not affected at all, 10 affected a lot) Visual Analog Scale (VAS) and 5-point Likert (very good - good - medium - bad - very bad). There is no total score from the form. Each question is evaluated on its own.
次要结局
- Pelvic Organ Symptom Score(Baseline and at 2, 6, 10 and 14 weeks postoperatively.)
- Sexual Function(Baseline and after 14 weeks)
- Anxiety(Baseline and at 2, 6, 10 and 14 weeks postoperatively.)
- Nursing Diagnosis Checklist(At 2, 6, 10 and 14 weeks postoperatively.)
- Satisfaction Evaluation Form(At 14 weeks postoperatively.)
研究者
Nazlı Özbek
Principal Investigator
Saglik Bilimleri Universitesi