| Protocol ID | NCT05053360 |
| Registration Date | 2021-09-22 |
| Status | completed |
| Sponsor | Inova Health Care Services |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2021-08-17 |
| Last Patient Out | 2023-04-14 |
| Publication | y |
| Gender % | FEMALE |
| Mean Age | 18 Years - 45 Years |
NCT05053360
Effects of Healing Touch on Pain and Anxiety in Women After Cesarean
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5252ms / 10598 tok |
GLM
glm-5.1 7182ms / 9309 tok |
OPENAI
gpt-4o Thinking: o3 3054ms / 9166 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
inpatient
inpatient → inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — The intervention is delivered to women after cesarean delivery while they are hospitalized post-operatively, which represents an inpatient setting with overnight stays.
|
inpatient
inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
|
inpatient
outpatient → inpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: inpatient — The intervention occurs after cesarean delivery, implying participants are hospitalized post-operatively, which is an inpatient setting.
|
OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility |
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — This is a fully powered RCT with 210 participants designed to evaluate clinical effectiveness of Healing Touch on pain and anxiety outcomes with appropriate statistical methodology.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The trial is a randomized controlled trial with a large enrollment of 210 participants and primary clinical outcomes focused on measuring pain and anxiety, rather than feasibility metrics.
|
fully powered RCT
N/A → fully powered RCT
shaky reasoning✓ Unanimous
Initial: N/A
Requery: fully powered RCT — The trial has a sample size of 160 and primary clinical outcomes related to the effectiveness of Healing Touch on pain and anxiety, indicating it is designed for clinical effectiveness.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | yes | yes | yes | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
no
no → no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — All outcomes measure pain and anxiety levels, which are symptom-focused and covered by the symptom/QoL/dignity/cost categories.
Thinking: no — Both primary outcomes (pain and anxiety) are symptom measures, with no other outcome categories formally listed.
|
yes
yes
shaky reasoning✗ No consensus
Initial: yes
|
no
no → yes → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The study aims to assess the feasibility of introducing Healing Touch as a therapy, which is an outcome not directly related to symptom/QoL/dignity/cost categories.
Thinking: yes — Besides pain and anxiety symptoms, the study plans to assess the feasibility of introducing Healing Touch, which is a feasibility metric outside symptom/QoL/dignity/cost categories.
|
|
| pharmacologic_sub | N/A | N/A | N/A | OK |