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临床试验/NCT06162156
NCT06162156招募中不适用

The Effect of Back Massage After Cesarean on Pain, Anxiety, Sleep, Breastfeeding, Comfort, Uterine Involution and Physiological Parameters

T.C. ORDU ÜNİVERSİTESİ2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
78
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

The aim of this study is to examine the effect of back massage application after cesarean section on women's pain, anxiety, sleep, breastfeeding, comfort, uterine involution process and physiological parameters. This research is a randomized controlled experimental type study with a pretest-posttest control group. In the research, after obtaining the necessary permissions and the ethics committee report, the application will be carried out to women who have given birth by cesarean section at the State Hospital and meet the criteria for inclusion in the study. Personal Information Form, Richard Campbell Sleep Scale, Trait-Trait Anxiety Inventory, Postpartum Comfort Scale, Bristol Breastfeeding Evaluation Tool, Visual Analog Scale for Pain, Uterine Involution Evaluation Form, Physiological Parameter Form will be used in the research.

详细描述

The aim of this study is to examine the effect of back massage after cesarean section on women's pain, anxiety, sleep, breastfeeding, comfort, uterine involution process and physiological parameters. This research is a randomized controlled experimental type study with a pretest-posttest control group. Personal Information Form, Richard Campbell Sleep Scale, Trait-Trait Anxiety Inventory, Postpartum Comfort Scale, Bristol Breastfeeding Evaluation Tool, Visual Analog Scale for Pain, Uterine Involution Evaluation Form, Physiological Parameter Form will be used in the research.

Collection of Data This research is a randomized controlled experimental type study with a pretest-posttest control group. The data of the research will be collected after the necessary institutional permission and ethics committee approval have been obtained. Data will be collected in three stages. Women who meet the inclusion criteria for the study will be informed about the method to be followed in the research. Those who want to participate in the research will read and sign the volunteer information form.

First Stage:

Women who apply to the selected hospital, meet the inclusion criteria and agree to participate in the study will be visited 12 hours after cesarean delivery, the women will be informed, verbal and written consent will be obtained from women who want to participate in the study, and pre-test data will be collected by the researcher. Before randomization to the intervention and control groups, the researcher will give general information to the mothers about the research at the 12th hour after cesarean section and their written informed consent will be obtained. The pre-test data of the research were collected face to face in an average of 20 minutes with the 'Personal Information Form', 'Trait-Trait Anxiety Inventory', 'Postpartum Comfort Scale', 'Bristol Breastfeeding Evaluation Tool', 'Uterus Involution Evaluation Form' and 'Physiological Parameter Form'. It will be filled in by the participants themselves using the interview technique. The height of the fundus section of the uterus, heart rate, body temperature, oxygen saturation, respiratory rate and blood pressure physiological parameters will be monitored by the researcher.

Second Stage:

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
Single (Outcomes Assessor)

盲法说明

Which group will be the intervention group and which group will be the control group will be determined by lottery. After the participant agrees to participate in the research, the person will draw envelopes from sealed envelopes by lottery and thus it will be determined which group he/she is in. Since the researcher and the mothers, who are massage practitioners, knew which group they were included in, the data collection phase of the study could not be blinded. Since the statistical analysis of the study will be performed by an independent statistician other than the researcher, the statistical analysis phase is blind. Therefore, the study is single blinded.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers who gave birth at the age of 18 and over
  • The one who is married
  • At least primary school graduate
  • Giving by cesarean section
  • Those who had a cesarean section with regional anesthesia
  • Having a single, healthy newborn at full term
  • Those who did not experience any problems during pregnancy
  • Pain intensity is 40 mm or more according to the Visual Analogue Scale
  • Does not react negatively to any attempt at touch, such as massage
  • The tissue integrity in the area to be massaged is complete and healthy
  • Women who agree to participate in the research will be included in the study

排除标准

  • Those who gave birth by cesarean section before the 37th week of pregnancy
  • Having diseases such as heart disease, diabetes, hypertension
  • Receiving controlled analgesia after cesarean section
  • Having received a psychiatric diagnosis such as anxiety and depression
  • Those who develop postpartum complications
  • Women who want to leave the research at any stage of the research will be excluded from the research

结局指标

主要结局

Visual Analog Scale

时间窗: twenty four hours

It is used for pain assessment in musculoskeletal and other clinical evaluations. VAS is used to convert some values that cannot be measured numerically into numerical values. It is a frequently used measurement tool because it is easy to apply and safe. At the left end of the 10 cm long horizontal line are the words 'I have no pain' and at the right end the words 'I have pain'. The individual is told to mark the point on this horizontal line that best expresses the intensity of pain in his body. The distance of the point marked by the individual to the left end is measured and the pain score is determined. As the VAS value approaches 10, the intensity of the pain increases, and as it approaches 0, the intensity decreases. The lowest score from the scale is 0 and the highest score is 10.

次要结局

  • Richard-Campbell Sleep Scale(twenty four hours)
  • Postpartum Comfort Scale(twenty four hours)
  • State Anxiety Inventory (STAI Form)(twenty four hours)
  • Bristol Breastfeeding Assessment Tool(twenty four hours)
  • Uterine Involution Evaluation Form(twenty four hours)
  • Physiological Parameter Form(twenty four hours)

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Guler

PhD student

T.C. ORDU ÜNİVERSİTESİ

研究点 (2)

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