Mechanical massage with an electric massage chair and preoperative anxiety in planned caesarean section: a randomised control trial
Anxiety at planned caesarean
This study is a prospective, single-centre, parallel-group, assessor-blinded randomized controlled interventional trial evaluating the effect of mechanical massage using an electric massage chair on preoperative anxiety in women undergoing planned caesarean section. Eligible participants are pregnant women aged ≥18 years with singleton pregnancies at ≥37 weeks’ gestation and clinically significant preoperative anxiety (Perioperative Anxiety Scale-7 [PAS-7] score ≥8). Participants will be randomized in a 1:1 ratio using computer-generated random allocation with sequentially numbered opaque envelopes into either the intervention arm (ON-MASSAGE) or control arm (OFF-MASSAGE). Participants in the ON-MASSAGE arm will receive two 30-minute sessions of seated mechanical massage using the Zero Healthcare uShine Massage Chair. The massage programme will be standardized to a preset “relax/gentle” mode at fixed low intensity (approximately level 2/5). Sessions will be conducted one day prior to surgery and within four hours before the planned caesarean section. Participants will remain in a semi-reclined position during the intervention to minimise aortocaval compression. Reduction in massage intensity is permitted for comfort; however, participants will not be allowed to increase intensity or alter programme mode. Participants in the OFF-MASSAGE control arm will sit in the identical massage chair for the same duration and positioning, but with the massage function deactivated (inactive sham-device seated control). This control is intended to account for environmental exposure, resting effects, and staff interaction. Baseline maternal vital signs, fetal heart rate (as per routine obstetric care), and symptom screening will be performed prior to each session. Outcome assessors and data analysts will remain blinded to group allocation.
1. PAS-7 score ≥ 8 out of a maximum score of 28, indicating preoperative anxiety 2. Planned caesarean section 3. Singleton pregnancy 4. Term pregnancy (gestational age ≥ 37 weeks) 5. Adult (age ≥ 18 years) 6. Reassuring fetal status (based on CTG monitoring as part of standard care) 7. Able to give consent 8. Able to communicate in English or Bahasa Melayu
1. Known psychiatric illnesses (e.g., depression, bipolar disorder, schizophrenia, etc.) requiring current medications or other treatment. 2. Gross fetal anomalies 3. Placenta praevia 4. Morbidly adherent placenta spectrum 5. Major maternal medical disorders (Eg: cardiac disease, renal failure, etc)