Effect of Postoperative Oral Rinsing on Thirst-Related Discomfort, Comfort Level, and Bowel Sounds in Individuals Undergoing Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Scores of Mental State Assessment pre-test post-test on experimental group
研究概览
简要总结
The aim of this study is to evaluate the effects of oral rinsing with water in the postoperative period on thirst, comfort level, and bowel motility in patients undergoing abdominal surgery under general anesthesia.
This study was conducted as a randomized controlled trial with pretest-posttest design, including intervention and control groups. It was carried out between June 2024 and December 2024 with patients undergoing elective abdominal surgery. Sample size was calculated using G*Power 3.1.9.7 software, with an effect size of 0.50, α=0.05, and power=0.85. A total of 82 participants (41 per group) were initially planned, and considering a 10% data loss, the study was completed with 98 participants (49 in each group). Patients were stratified according to their diagnoses and randomized in a 1:1 ratio using block randomization with a random number table.
Three data collection forms were used. SPSS 22.00 package program was used to analyze the data. Skewnes-Kurtosis analyses were performed to determine the conformity of the data to a normal distribution. Frequency (n) and percentage (%) distributions were calculated to determine the sociodemographic and clinical characteristics of the participants. A t-test for independent samples was used to determine the mean differences between two independent groups, a t-test for dependent samples was used to compare pre- and post-intervention measurements, and a single-factor analysis of variance (ANOVA) was used for repeated measures. Cohen's d effect size was calculated to assess the significance of the difference between the groups in terms of the intervention. Statistical significance was accepted as p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
This study used a stratified random sampling method. Patients were stratified by clinical diagnosis and gender and randomized into blocks. Using a random number table, the first patient to arrive was assigned to the experimental group, and subsequent patients were sampled using a 1:1 allocation method until strata and blocks were equal in both groups.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Included Criteria
- •To communicate,
- •Aged 18 or older,
- •Agreed to participate
- •Scheduled for elective surgery.
排除标准
- •Over 80 years old,
- •Had a mental disorder that prevented them from rinsing their mouth,
- •Unconscious after surgery, were at
- •Risk of swallowing water during rinsing,
- •Underwent emergency surgery.
- •Refusion Criteria
- •Refused to complete the post-test
- •Intensive care after surgery
研究组 & 干预措施
Abdominal surgery patients receiving oral rinsing
Abdominal surgery patients
干预措施: oral rinsing (Other)
rutine service operation
Abdominal surgery patients
干预措施: rutine service operation (Other)
结局指标
主要结局
Scores of Mental State Assessment pre-test post-test on experimental group
时间窗: 1 day
Mini Mental State Assessment (MMSA): A cognitive screening tool with 11 items in five domains (orientation, registration, attention/calculation, recall, language). Scores range 0-30; ≤23 indicates impairment. Administration takes 5-10 minutes. Turkish validity and reliability are established.
Scores of Surgical Period Thirst Discomfort pre-test post-test on experimental group
时间窗: 1 day
Surgical Period Thirst Discomfort Scale (SPTDS): Adapted to 6 items with a 3-point Likert scale (0-2). Total score is 0-12; higher scores indicate greater thirst-related discomfort.Surgical Period Thirst Discomfort Scale (SPTDS)
Scores of Surgical Period Thirst Discomfort pre-test post-test on control group
时间窗: 1 day
Surgical Period Thirst Discomfort Scale (SPTDS): Adapted to 6 items with a 3-point Likert scale (0-2). Total score is 0-12; higher scores indicate greater thirst-related discomfort.Surgical Period Thirst Discomfort Scale (SPTDS)
Personal Information experimental group
时间窗: 1 day
Personal Information Form: Developed by researchers based on literature and clinical observation. The first section includes demographic and clinical data (age, gender, education, diagnosis, preoperative fasting time, postoperative oral intake time). The second section records bowel sounds.
Comfort levels pre-test post-test on experimental group
时间窗: 1 day
VAS-10: A 10-cm line used to evaluate comfort; 0 = lowest, 10 = highest comfort. Higher scores reflect greater comfort.
Scores of Mental State Assessment pre-test post-test on control group
时间窗: 1 day
Mini Mental State Assessment (MMSA): A cognitive screening tool with 11 items in five domains (orientation, registration, attention/calculation, recall, language). Scores range 0-30; ≤23 indicates impairment. Administration takes 5-10 minutes. Turkish validity and reliability are established.
Personal Information control group
时间窗: 1 day
Personal Information Form: Developed by researchers based on literature and clinical observation. The first section includes demographic and clinical data (age, gender, education, diagnosis, preoperative fasting time, postoperative oral intake time). The second section records bowel sounds.
Comfort levels pre-test post-test on control group
时间窗: 1 day
VAS-10: A 10-cm line used to evaluate comfort; 0 = lowest, 10 = highest comfort. Higher scores reflect greater comfort.
次要结局
未报告次要终点
研究者
Pınar YILMAZ EKER
Asst. Prof. Dr.
Cumhuriyet University