跳至主要内容
临床试验/CTRI/2025/08/093457
CTRI/2025/08/093457尚未招募不适用

Effect of Diaphragmatic breathing and Bensons Relaxation Technique on Anxiety and Fatigue during Pregnancy: A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Multidimensional Assessment of Fatigue Scale

研究概览

简要总结

Pregnancy often brings physical, emotional, and psychological stress. Anxiety and fatigue are common due to hormonal, physiological, and psychological changes. Pharmacological treatments pose risks; hence, non-pharmacological methods like relaxation techniques are explored. Diaphragmatic breathing promotes relaxation by improving oxygenation and lowering respiratory rate. Benson’s relaxation technique is a simple, evidence-based stress reduction method using mindful breathing and passive awareness.

Methodology:

Participants: Pregnant women (2nd or 3rd trimester) with mild to moderate anxiety/fatigue. Sample Size: 60 women (30 per group).Group A: Diaphragmatic breathing only. Group B: Diaphragmatic breathing + Benson’s relaxation technique .Duration: 4 weeks. Outcome Measures :Multidimensional Assessment of Fatigue (MAF). Beck Anxiety Inventory (BAI). Pittsburgh Sleep Quality Index (PSQI).

Intervention:

Pre Intervention Baseline Assessment (MAF+BAI+PSQI)

Group 1

•Diaphragmatic Breathing.   Participant will be in supine position.

•Instruction for participants: (Given in local Language)

oBend your knees while lying on your back on a level surface, such as your bed. If it’s more comfortable, you can support yourself with a pillow beneath your head and legs.

oTouch your tummy, right below your rib cage, with one hand and your upper chest with the other.

oTake a calm, deep breath through your nose and direct it toward your lower abdomen. While the hand on your tummy should rise, the one on your chest should stay motionless.

oAs you release the breath through pursed lips, contract your abdominal muscles and allow them to drop inward. The hand on your stomach ought to return to its starting position.

•  Duration:

o  Five inspirations and expirations per set

o  2 sets per day

o  5 days per week

o  For 4 weeks

Group 2

Diaphragmatic breathing + Bensons relaxation technique

•  Diaphragmatic breathing:

o  Same as group A

•  Bensons relaxation technique

Instructions for participants

O Take a seat comfortably and silently.

O Shut your eyes.

O Start at your feet and work your way up to your face, deeply relaxing every muscle.  Keep them at ease.  [Calm down—and your thoughts will stop.]

O Use your nose to breathe.  Pay attention to your breathing.  Say the word "one"* to yourself in a quiet voice as you exhale.  Say "one"*, for instance, and then exhale, then repeat "one."  Breathe naturally and effortlessly.

O Continue for 10 minute You may open your eyes to check the time, but do not use an alarm. When you finish, sit quietly for several minutes, at first with your eyes closed and later with your eyes opened. Do not stand up for a few minutes.

Do not worry about whether you are successful in achieving a deep level of relaxation. Maintain a passive attitude and permit relaxation to occur at its own pace. When distracting thoughts occur, try to ignore them by not dwelling upon them and return to repeating "one."*

O With practice, the response should come with little effort. Practice the technique once or twice daily, but not within two hours after any meal, since the digestive processes seem to interfere with the elicitation of the Relaxation Response.

*Choose any soothing, mellifluous sounding word, preferably with no meaning or association, to avoid stimulation of unnecessary thoughts.

•  Duration:

o  10 minutes

o  2 times per day

o  5 days per week

o  For 4 weeks

Post Intervention Baseline Assessment (MAF+BAI+PSQI)

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Pregnant women in their second or third trimester.
  • 2.Participants experiencing mild to moderate anxiety or fatigue.
  • 3.Individuals willing to participate and practice the techniques regularly.

排除标准

  • 1.Participants with severe medical conditions or complications during pregnancy.
  • 2.Individuals with a history of psychiatric disorders requiring medication.
  • 3.Those already practicing similar relaxation or breathing techniques.
  • 4.Participants unwilling to comply with the study protocol.

结局指标

主要结局

Multidimensional Assessment of Fatigue Scale

时间窗: week0-week4

Becks Anxiety Inventory (BAI)

时间窗: week0-week4

次要结局

  • The Pittsburgh Sleep Quality Index (PSQI)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Shruti kukreja

Dr APJ Abdul Kalam college of Physiotherapy

研究点 (1)

Loading locations...

相似试验