跳至主要内容
临床试验/NCT05436015
NCT05436015招募中不适用

Nature in Hospital - Effectiveness of Virtual Nature-based Intervention During First Stage of Labour: A Feasibility Study and Pilot RCT

University of Oulu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Anxiety measured with STAI-Y1, change is being assessed

研究概览

简要总结

Rationale: The birth environment effects on childbirth experience and feelings of security of birthing women. Fear of Childbirth (FOB) is experienced by 6-10% of women in Finland and FOB predicts postpartum depression. Real or artificial views of nature have several positive health effects including reduction of anxiety and stress. Feasible and cost-effective nature-based intervention is being studied in this pilot RCT.

Objectives: To develop a virtual nature-based intervention for the delivery ward and to assess its feasibility and effectiveness. The study assesses how the nature-based intervention carried out during the first stage of labour affects the anxiety, fear, stress, pain and childbirth experience of birthing women. The aim is to provide evidence-based information on the feasibility and effectiveness of this intervention.

Methods: Sixty women will be randomized into two groups: Nature-based intervention group and control group. All participants will have assessments during first stage of labour in nature-based intervention group before and after intervention and in control group at the same time without intervention. In both groups also 2-6 hours after childbirth, 2 days after childbirth and 2 weeks after childbirth.

详细描述

During the piloting and feasibility assessment phase of intervention, the nature-based intervention is tested and its feasibility and preliminary effectiveness on the anxiety, fear, stress, pain and childbirth experience is assessed. Phase II consists of a pilot RCT (Randomized Control Trial) study and a qualitative interview study. The nature-based intervention includes videos filmed in the nature of Northern Finland and takes place during 1st stage of labour before the need for medical pain relief. The pilot phase test group (N=30) will receive a nature-based intervention in addition to standard care during childbirth and the control group (N=30) receives standard care treatment. The study includes parturients (weeks of pregnancy 37+0-41+6) entering delivery ward during active labour. Before childbirth the participants in the study are measured for anxiety, stress, fear of childbirth and pain, and feeling of safety. After childbirth, the childbirth experience is assessed in the deliveryward and before discharge in postnatal ward. Before discharge, postpartum experience with anxiety, fear of childbirth and depression is also measured. During the pilot phase at two weeks, childbirth experience, anxiety and depression are assessed. Data related to childbirth and mental health diagnoses is also collected. The data is analysed using statistical methods. In the pilot phase, the participants in the intervention group (N=5-10) will be interviewed two weeks after childbirth. Thematic interview about the experiences of nature-based interventions of midwives in the delivery room (N=5-10) will also take place. Interviews are recorded and the materials are analysed by inductive content analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

Statistician, who is not involved in the study has done block-randomization with variable block-sizes (2,4,6) by StatsDirect program for two groups; an intervention and control group. All study team members and participants will be blind to group allocation with the exception of one research assistant who will not be involved in providing the intervention to the participants or data analysis. Delivery ward staff (midwives) asks informed consent and after receiving it, performs the allocation.

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • •full-term pregnancy (h 37+0 - 41+6)
  • •childbirth at active first-stage of labour

排除标准

  • •An individual who meets any of the following criteria will be excluded from participation in this study:
  • •severe vision or hearing loss
  • •communication is possible only via interpreter
  • •childbirth in second stage of labour
  • •expected complications during childbirth

研究组 & 干预措施

Intervention Group

Experimental

In addition to usual standard care during childbirth in hospital, the intervention group will receive a virtual nature-based intervention

干预措施: Virtual nature-based intervention (Other)

Control Group

No Intervention

The control group receives the usual standard care during childbirth in hospital

结局指标

主要结局

Anxiety measured with STAI-Y1, change is being assessed

时间窗: 1) Pre-intervention 2) Two days after childbirth 3) Two weeks after childbirth

The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most used version of the STAI meter and only it's STATE-A section is utilized. Woman evaluates own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.

次要结局

  • Stress with physiological measures: Blood pressure variation, change is being assessed(Pre-intervention and immediately after the intervention)
  • Maternal Depression with EPDS, change is being assessed(1) two days after childbirth 2) two weeks after childbirth)
  • Stress with physiological measures: Heart rate, change is being assessed(Pre-intervention and immediately after the intervention)
  • Stress with physiological measures: Respiration rate, change is being assessed(Pre-intervention and immediately after the intervention)
  • Stress with physiological measures: Heart rate variability, change is being assessed(Pre-intervention and immediately after the intervention)
  • Stress with serum cortisol, change is being assessed(Pre-intervention and immediately after the intervention)
  • Fear of Childbirth with W-DEQ version Fear of Childbirth W-DEQ version Fear of Childbirth with W-DEQ version B(Two days after childbirth)
  • Birth Experience with NRS, change is being assessed(1) Two - six hours after childbirth 2) two days after childbirth)
  • Birth Experience with DSS, change is being assessed(1) Two - six hours after childbirth 2) two days after childbirth 3) two weeks after childbirth)
  • Stress with physiological measures: Blood pressure, change is being assessed(Pre-intervention and immediately after the intervention)
  • Stress with physiological measures: Baroreflex sensitivity, change is being assessed(Pre-intervention and immediately after the intervention)
  • 1) Fear 2) Pain and 3) Feeling of Security with VAS, change is being assessed(Pre-intervention and immediately after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effectiveness of Virtual Nature-based Intervention... | 临床试验