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临床试验/NCT03755284
NCT03755284已完成不适用

The Effect Of Sacral Massage On Labour Pain and Anxiety: A Randomized Controlled Trial

Semra Çevik, phD2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The state-trait anxiety inventory (STAI FORM TX-I) evaluated

研究概览

简要总结

Nonpharmacologic pain control methods, which are increasingly becoming widespread in coping with the labour pain, are the methods that allow women to completely relax without using any medication and direct them to perceive the pain at the lowest level. This study was conducted to determine the effect of sacral massage, on labour pain and anxiety. This study was conducted as a randomized controlled experimental study at Bağcılar Training and Research Hospital, Obstetrics and Gynecology Clinic between March and October 2016.

Hypotheses of the Study

  1. Massage applied to the sacral region decreases the perception of a woman's labour pain.
  2. Massage applied to the sacral region decreases the woman's levels of concern and anxiety about labour.
  3. Massage applied to the sacral region increases the woman's satisfaction with the labour

详细描述

Study design

This was a randomized and controlled experimental study aimed to determine the effects of sacral massage on labour pain and anxiety.

Setting and samples

The study was performed in volunteer pregnant women who applied to xxx Training and Research Hospital, Delivery Unit, to undergo their first labour between January 25 and October 25, 2016. This unit contains 1 delivery room (with 2 tables), 2 labour follow-up rooms (with 5 beds), 1 postpartum room (with 5 beds) and 1 nursing room.

According to hospital records, in all, 342 pregnant women who applied to xxx Training and Research Hospital, Delivery Unit to undergo their first labour between January 25 and October 25, 2016, constituted the population of the study. The following inclusion criteria were used to determine participation in the study: (1) 19-40-year-old primiparous pregnant women;(2) Singleton pregnancies between 38-42 weeks; (3) Pregnant women whose labour began spontaneously; (4) Pregnant women with a healthy foetus; (5) Pregnant women without any complications that may cause dystocia during labour; (6) Pregnant women for whom analgesia and anaesthesia were not used during the first phase of labour; (7) Pregnant women who volunteered to participate in the research and who could establish verbal communication. In addition, Pregnant women with high-risk pregnancies, with caesarean section indication, and Pregnant women with a chronic illness were excluded.

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
None

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 19-40-year-old primiparous pregnant women;
  • Singleton pregnancies between 38-42 weeks;
  • Pregnant women whose labour began spontaneously;
  • Pregnant women with a healthy foetus;
  • Pregnant women without any complications that may cause dystocia during labour;
  • Pregnant women for whom analgesia and anaesthesia were not used during the first phase of labour;
  • Pregnant women who volunteered to participate in the research and who could establish verbal communication.

排除标准

  • Pregnant women with high-risk pregnancies, with caesarean section indication, and
  • Pregnant women with a chronic illness were excluded.

研究组 & 干预措施

sacral Massage Group

Experimental

The massage was applied only to the pregnant women in the intervention group at every phase of labour. There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.

For the pregnant women included in the experimental group:

In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.

干预措施: Sacral Massage (Other)

Control Group

No Intervention

There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.

One-on-one interviews were conducted with the pregnant women, and the voluntary disclosure forms, which explained the purpose of the study, were completed.

The prepared questionnaire form was applied. Routine nursing/midwifery care was applied. The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the active (5-7 cm) phase.

The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases.

Birth action follow-up form and postpartum interview forms were applied

结局指标

主要结局

The state-trait anxiety inventory (STAI FORM TX-I) evaluated

时间窗: 6 hours

The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the massage in the active (5-7 cm) phase.To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely.the STAI FORM TX-I was used in the active (5-7 cm) phase in the control group and in the active (5-7 cm) phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour.

次要结局

  • The Visual Analogue Scale (VAS) evaluated(6 hours)

研究者

发起方
Semra Çevik, phD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Semra Çevik, phD

Assiatant Professor

University of Gaziantep

研究点 (2)

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